Chronic Low Back PainNCT06148896
Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Low Back Pain
A study testing GrExPACT and GrEx in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This two-armed randomized controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with acceptance and commitment therapy led by physiotherapist (GrExPACT) (experimental intervention) as compared to Group Exercise alone (GrEx) (control intervention) for elderly with chronic low back pain (LBP)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- GrExPACT and GrEx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ages ≥ 65;
- Nonspecific LBP for > 3 month;
- Stratified as medium-risk category (i.e., total score ≥ 4 and sub score ≤ to 3) and high-risk category (i.e., total score ≥ 4 and sub score ≥ 4) using the STarT Back Screening Tool;
- Roland Morris Disability Questionnaire (RMDQ) score ≥ 5 (with reference to the minimal level of detectable change)(30, 31);
- Able to walk with or without assistive aid and with Modified Functional Ambulatory Category ≥ 6 (32);
- Able to read Chinese characters;
- Able to speak and understand Cantonese; and
- Abbreviated mental test (AMT) ≥ 6 (33).
Who cannot join
- Specific cause of LBP such as tumor, infection, or apparent neurological deficit;
- Serious uncontrolled co-morbidities or systematic diseases which is contraindicated to exercise;
- Orthopedic condition like recent fracture require immobilization and not fitting for exercise;
- Unstable cardiac, pulmonary, metabolic, and psychological disease requiring acute care;
- Severe cognitive, language or hearing deficits;
- Spinal surgery in the past 12 months as not to confound with effect of surgery;
- People who had prior treatment with ACT at any time; or
- People who had received physiotherapy treatment in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Kowloon
Kit Chi Yeung, 852 66957358, angelinayeungykc@gmail.com
About this study
Official title: Effects of Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
This two-armed randomized controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with acceptance and commitment therapy led by physiotherapist (GrExPACT) (experimental intervention) as compared to Group Exercise alone (GrEx) (control intervention) for elderly with chronic low back pain (LBP) whom are stratified as medium or high-risk using the STarT Back Screening Tool on functional recovery as measured by Roland Morris Disability Questionnaire as the primary outcome and a list of secondary outcomes which include Committed Action questionnaire, Chronic Pain Acceptance questionnaire, Patient self-efficacy Questionnaire, Brief Pain Inventory, Patient Specific Functional Scale, Short Physical Performance Battery and a patient satisfaction survey, immediately after a 5-week programme as well as at 3-month follow-up.
The list of hypotheses to be tested in this RCT include:
- For main effect: Intervention H0: The outcome means for the intervention of GrExPACT and GrEx are equal H1: The outcome means for the intervention of GrExPACT and GrEx are not equal
- For main effect: Time H0: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are equal H1: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are not equal
- For interaction: Intervention x Time H0: There is no interaction between the intervention and time H1: There is interaction between the intervention and time
Read the detailed description
Sample size:
The sample size was calculated with reference to the effect size of 0.052 (partial eta square) being worked out from the primary outcome of Roland Morris Disability Questionnaire obtained from the pilot study. G*Power 3.1.9.4 was used to calculate the sample size. With power of 0.95 and alpha value of 0.05, the total sample size is 68. With reference to the attrition rate of approximately 20% in the pilot study, the sample size will become 43 subjects in each group and with total of 86 subjects will be recruited.Subjects will be recruited from local community elderly community centers.
Randomization:
The subjects will be randomly assigned by the principal investigator to either intervention group of GrExPACT or control group of GrEx using computerized randomization software. Permuted blocked randomization with a block size of four and stratified by gender and STarT Back category will be used as to ensure the groups are balanced. The allocation will be concealed and stored in an encrypted file storing in a password protected computer. Corresponding group therapy class will be arranged to the patient accordingly.
Study design:
86 subjects with chronic nonspecific LBP subject will first receive a 30-minute triage screening by a physiotherapist for inclusion criteria, exclusion criteria and red flags as to confirm the subjects are belonging to chronic nonspecific LBP and is suitable for the study. The red flags include night pain, 24-hour pain, unexplained weight loss, night sweats, fever, change in bowel and urinary habits and saddle anesthesia. Subjective examination for body chart and physical examination include trunk range of motion, myotome, dermatome, reflexes, palpation, and neuro-tension test will be performed when applicable.
Each subject will participate weekly group program for five consecutive weeks after the group randomization. The size of the group is about 10. Each session for both intervention group and control group will last for 105 min and will receive 60-minute group exercise therapy includes supervised stretching, mobilization, stabilization and strengthening exercise for the muscles around lumbar, hips and low limbs followed by functional and aerobic training. The exercises are selected with reference to the National Institute for health and care Excellence (NICE) guidelines, systematic review for physical activities for elderly with chronic LBP and experience from the previous pilot trial which is safe and effective for elderly with nonspecific chronic LBP. The exercise will be taught to patient progressively from lying to sitting in first two sessions and adding more advance standing to functional and aerobic training in subsequent sessions. The resistance of the TheraBand and step height for functional training will tailor made and increase according to individual capability. Each patient will be given an exercise pamphlet, goal setting worksheet and home exercise record sheet. Patients are encouraged to utilize local community exercise facilitates and bring back the home exercise record sheet each time for checking of compliance of practicing home exercise.
Both groups of patients will have a physiotherapist leading discussion. For the GrEx group, the discussion will last for 45 minutes. It involves discussion for back care and exercise referencing to the back school that is a common educational and training program given to patients with low back pain. The content includes anatomy of the spine, cause for pain, self-management, correct manual lifting technique, ergonomic advice, and benefit of regular exercise. For the GrExPACT group, the discussion will use the Acceptance and Commitment Therapy (ACT) approach and will also last for 45 minutes. The content of the discussion will follow the protocol-based ACT extracted from the protocol for the contextual pain management by physiotherapy being used in INPUT center of St Thomas Hospital, London and physiotherapy informed by acceptance and commitment therapy protocol (PACT) .
Qualification of the intervention provider:
The intervention providers are registered physiotherapist in Hong Kong who had more than 30 years of clinical experience in treating patient with musculoskeletal problem at public physiotherapist outpatient clinic. For the background of ACT training, the physiotherapists had received training for taught course for ACT and had participated in a two-day clinical attachment for the contextual pain management program in INPUT Center at St. Thomas Hospital in London of United Kingdom in 2018. Besides the participation in the local pilot trial for GrExPACT study, they had also participated in the development for the local clinical service team for stratified care and combined the physical and psychological approach in management of high-risk back pain patients since 2015.
Data processing and statistical analysis:
The statistical analysis will be carried out using IBM SPSS version 28 software. The demographically data will be presented by descriptive statistics. For continuous data, it will be presented as mean, standard deviation and range. For categorical data, it will be presented as frequency and percentage. Normality will be first screened by Boxplot, and further assessed by the Shapiro-Wilk test. For the primary and secondary outcomes, two way repeated measure ANOVA will be carried out. For the effect of time, the post hoc test will be carried out for testing the differences of outcome scores for pre-intervention verse immediate after the program; pre-intervention verse at 3 months; and immediate after the program verse at 3 months. For the effect of intervention, post hoc tests at each time point will be carried out when necessary. Significance was set at p < 0.05. Intention-to-treat analysis will be used and missing data will be replaced with data from the nearest previous non-missing data. Effect sizes (Partial eta squared) will also be computed to establish the magnitude of the treatment effects. The effect sizes will interpreted as small (η2=0.01), medium (η2=0.06) or large (η2=0.14).
Clinical significance:
In the management of elderly patient with chronic nonspecific low back pain (LBP), to face the aging population, growing high patient volume and limited resources in health care, an effective and efficient service model is urged. The service model of GrExPACT in the present randomized control trial involve tailor made and resources saving strategy by using concept of stratified care with STarT Back Screening Tool, physical therapy with group exercise and psychological therapy with group ACT lead by physiotherapist. With the present study, the effectiveness, synergistic effect, and adaptability to local culture for combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT) could be studied. The potential positive finding may enhance the role of physiotherapist using the psychological approach in the management of chronic nonspecific LBP and provide evidence support for the proposed more comprehensive, tailor made and resources saving service model of GrExPACT. This may help to reform a more effective and efficient model of care in Hong Kong.
- Conditions
- Chronic Low Back Pain
- Being tested
- GrExPACT, GrEx
- Keywords
- Elderly, Chronic non specific low back pain, Group exercise, Acceptance and Commitment therapy led by physiotherapist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrExPACTBehavioural
Also called No other intervention (No drug, No device)
Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapy
GrExBehavioural
Also called No other intervention (No drug, No device)
Group physiotherapy exercise
| Study group | Role | What they receive |
|---|---|---|
| Group Exercise with acceptance and commitment therapy | Experimental | Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT) Receives: Behavioral: GrExPACT |
| Group Physiotherapy Exercise alone | Active comparator | Group Physiotherapy exercise alone (GrEx) Receives: Behavioral: GrEx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is a 24 self-administrated items scale which measures the level of disability of patients with LBP. Items are yes and no response in which the item will score 0 with negative response and score 1 for positive response. The score for the Roland Morris Disability Questionaire is the sum of scores of the items with positive response. A patient score can range from 0 to 24. The higher the score, the greater is the disability.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Secondary outcomes (7)
Committed Action Questionnaire
The Committed Action Questionnaire is a self-reported 8 item questionnaire assessing the construct of committed action from the psychological flexibility model of Acceptance and Commitment Therapy. It composed of two subscales naming values persistence which consist of 4 positively keyed items and nonreactive behavior which consist of 4 negatively keyed items. Each items requires to rate with a 7-point Likert scale ranging from 0 (never true) to 6 (always true). The score for items being negatively keyed need to be reversed before calculation of the total score. The sum of score for the eight items forming a total score ranging from 0 to 48. The higher the total scores the greater the committed action.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire 8 is a self-reported 8-item questionnaire used to measure the acceptance of pain. It composed of two subscales naming activity engagement and pain willingness. The 4 item under activity engagement evaluates the degree to which behaviors are limited or restricted by pain. The 4 item under pain willingness assesses the degree of effort directed at controlling pain. Each items requires to rate with a 7-point Likert scale ranging from 0 (never true) to 6 (always true). The score for the items under the subscale of pain willingness need to be reversed before calculation of the score. The sum of score for the eight items forming a total score ranging from 0 to 48. The higher the total scores the greater levels of pain acceptance.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Pain self-efficacy Questionnaire
Pain self-efficacy Questionnaire (PSEQ) is a self-reported 10-item questionnaire to evaluate the confidence of people with chronic pain to perform activities such as household chores, work and social activities while in pain. Each item needs to rate with a 7-point response scale ranging from 0 (not at all confident) to 6 (completely confident). The score of PSEQ is the sum of all 10 items yielding score ranging from 0 to 60. The higher the score the stronger is self-efficacy belief.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Brief Pain Inventory
The Brief Pain inventory is a self-administrated questionnaire measures the severity and impact of the clinical pain. The questionnaire has four items for pain intensity and seven items for interference on general activity, mood, walking ability, normal walk, relations with other people sleep and enjoyment of life. The items for Pain are rated from 0 (no pain) to 10 (pain as bad as you imagine) and the items for interference are rated from 0 (does not interfere) to 10 (completely interfere). The pain score can be calculated by averaging the 4 items related to pain and the interference score can be calculated by averaging the 7 items related to interference. The higher the score, the more worsen of the condition.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Patient Specific Functional Scale
The Patient Specific Functional Scale is a self-reported questionnaire assessing the functional change of patients with musculoskeletal disorders. Subjects will ask to identify up to five important activities that have difficulty to perform and rate for the difficulty level of each identified activity on an 11-point scale ranging from "0" represents unable to perform to "10" represents able to perform. The Patient Specific Functional Scale score is the average score for the listed activities. The higher the score the more worsen of the condition.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Short Physical Performance Battery
The Short Physical Performance Battery is an objective measurement of the balance, lower extremity strength and functional capacity in elderly over 65 years of age. It includes three subscale of chair to stand tests, gait speed test and hierarchical balance test. Each test is scored from 0 (worst performance) to 4 (best performance). Adding together the three-subscale score yield the total score ranging from 0 to 12. The higher the total score the better the physical performance.
Measured: Pre-intervention, immediate post-intervention and 3 month post-intervention
Patient satisfaction Survey
The patient satisfaction survey consists of 8 questions. One question concerns the compliance of exercise and rest of the seven questions concern the usefulness of the class. The subjects require rating from 0 (totally disagree) to 10 (totally agree) for their view to the questions. The questions include usefulness of the acceptance of pain concept, personalized goal setting, pamphlet, exercise taught, self-management concept, overall satisfaction, and overall improvement on back pain. The higher the score the higher the patient satisfaction.
Measured: immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start28 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This two-armed randomised controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with PACT (GrExPACT experimental intervention) as compared to Group Exercise (GrEx) alone led by physiotherapist (control intervention) for elderly with chronic LBP
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Man Ha Sharon Tsang, Doctor, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148896
- Sponsor's protocol ID
- RCT_YKC
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verhagen AP, Downie A, Popal N, Maher C, Koes BW. Red flags presented in current low back pain guidelines: a review. Eur Spine J. 2016 Sep;25(9):2788-802. doi: 10.1007/s00586-016-4684-0. Epub 2016 Jul 4.
PubMed 27376890National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/
PubMed 27929617Vadala G, Russo F, De Salvatore S, Cortina G, Albo E, Papalia R, Denaro V. Physical Activity for the Treatment of Chronic Low Back Pain in Elderly Patients: A Systematic Review. J Clin Med. 2020 Apr 5;9(4):1023. doi: 10.3390/jcm9041023.
PubMed 32260488Straube S, Harden M, Schroder H, Arendacka B, Fan X, Moore RA, Friede T. Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research-systematic review and meta-analysis. Pain. 2016 Oct;157(10):2160-2172. doi: 10.1097/j.pain.0000000000000640.
PubMed 27257858Jacobs, C. (2015). Contextual pain management physiotherapy. NPUT center of St Thomas Hospital London UK.
Godfrey E, Galea Holmes M, Wileman V, McCracken L, Norton S, Moss-Morris R, Pallet J, Sanders D, Barcellona M, Critchley D. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain. BMJ Open. 2016 Jun 7;6(6):e011548. doi: 10.1136/bmjopen-2016-011548.
PubMed 27267109Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
PubMed 6222486Tsang, R. C. (2004). Measurement properties of the Hong Kong Chinese version of the Roland-Morris disability questionnaire. Hong Kong Physiotherapy Journal, 22(1), 40-49.
McCracken LM. Committed action: an application of the psychological flexibility model to activity patterns in chronic pain. J Pain. 2013 Aug;14(8):828-35. doi: 10.1016/j.jpain.2013.02.009. Epub 2013 May 4.
PubMed 23651881Wong WS, McCracken L, Wong S, Chen PP, Chow YF, Fielding R. The Chinese version of the 8-item Committed Action Questionnaire (ChCAQ-8): A preliminary analysis of the factorial and criterion validity. Psychol Assess. 2016 Jun;28(6):e111-8. doi: 10.1037/pas0000187. Epub 2015 Jul 27.
PubMed 26214015Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.
PubMed 18824301Liu Y, Wang L, Wei Y, Wang X, Xu T, Sun J. Validation of a Chinese version of the Chronic Pain Acceptance Questionnaire (CAPQ) and CPAQ-8 in chronic pain patients. Medicine (Baltimore). 2016 Aug;95(33):e4339. doi: 10.1097/MD.0000000000004339.
PubMed 27537558Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
PubMed 16446108Lim HS, Chen PP, Wong TC, Gin T, Wong E, Chan IS, Chu J. Validation of the Chinese version of pain self-efficacy questionnaire. Anesth Analg. 2007 Apr;104(4):918-23. doi: 10.1213/01.ane.0000255731.24092.a5.
PubMed 17377107Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
PubMed 26303366
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06148896
- Acronym / sponsor ID
- RCT_YKC
- Conditions
- Chronic Low Back Pain
- Keywords
- Elderly, Chronic non specific low back pain, Group exercise, Acceptance and Commitment therapy led by physiotherapist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-armed randomized controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with acceptance and commitment therapy led by physiotherapist (GrExPACT) (experimental intervention) as compared to Group Exercise alone (GrEx) (control intervention) for elderly with chronic low back pain (LBP) whom are stratified as medium or high-risk using the STarT Back Screening Tool on functional recovery as measured by Roland Morris Disability Questionnaire as the primary outcome and a list of secondary outcomes which include Committed Action questionnaire, Chronic Pain Acceptance questionnaire, Patient self-efficacy Questionnaire, Brief Pain Inventory, Patient Specific Functional Scale, Short Physical Performance Battery and a patient satisfaction survey, immediately after a 5-week programme as well as at 3-month follow-up.
The list of hypotheses to be tested in this RCT include:
- For main effect: Intervention H0: The outcome means for the intervention of GrExPACT and GrEx are equal H1: The outcome means for the intervention of GrExPACT and GrEx are not equal
- For main effect: Time H0: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are equal H1: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are not equal
- For interaction: Intervention x Time H0: There is no interaction between the intervention and time H1: There is interaction between the intervention and time
Detailed description
Sample size:
The sample size was calculated with reference to the effect size of 0.052 (partial eta square) being worked out from the primary outcome of Roland Morris Disability Questionnaire obtained from the pilot study. G*Power 3.1.9.4 was used to calculate the sample size. With power of 0.95 and alpha value of 0.05, the total sample size is 68. With reference to the attrition rate of approximately 20% in the pilot study, the sample size will become 43 subjects in each group and with total of 86 subjects will be recruited.Subjects will be recruited from local community elderly community centers.
Randomization:
The subjects will be randomly assigned by the principal investigator to either intervention group of GrExPACT or control group of GrEx using computerized randomization software. Permuted blocked randomization with a block size of four and stratified by gender and STarT Back category will be used as to ensure the groups are balanced. The allocation will be concealed and stored in an encrypted file storing in a password protected computer. Corresponding group therapy class will be arranged to the patient accordingly.
Study design:
86 subjects with chronic nonspecific LBP subject will first receive a 30-minute triage screening by a physiotherapist for inclusion criteria, exclusion criteria and red flags as to confirm the subjects are belonging to chronic nonspecific LBP and is suitable for the study. The red flags include night pain, 24-hour pain, unexplained weight loss, night sweats, fever, change in bowel and urinary habits and saddle anesthesia. Subjective examination for body chart and physical examination include trunk range of motion, myotome, dermatome, reflexes, palpation, and neuro-tension test will be performed when applicable.
Each subject will participate weekly group program for five consecutive weeks after the group randomization. The size of the group is about 10. Each session for both intervention group and control group will last for 105 min and will receive 60-minute group exercise therapy includes supervised stretching, mobilization, stabilization and strengthening exercise for the muscles around lumbar, hips and low limbs followed by functional and aerobic training. The exercises are selected with reference to the National Institute for health and care Excellence (NICE) guidelines, systematic review for physical activities for elderly with chronic LBP and experience from the previous pilot trial which is safe and effective for elderly with nonspecific chronic LBP. The exercise will be taught to patient progressively from lying to sitting in first two sessions and adding more advance standing to functional and aerobic training in subsequent sessions. The resistance of the TheraBand and step height for functional training will tailor made and increase according to individual capability. Each patient will be given an exercise pamphlet, goal setting worksheet and home exercise record sheet. Patients are encouraged to utilize local community exercise facilitates and bring back the home exercise record sheet each time for checking of compliance of practicing home exercise.
Both groups of patients will have a physiotherapist leading discussion. For the GrEx group, the discussion will last for 45 minutes. It involves discussion for back care and exercise referencing to the back school that is a common educational and training program given to patients with low back pain. The content includes anatomy of the spine, cause for pain, self-management, correct manual lifting technique, ergonomic advice, and benefit of regular exercise. For the GrExPACT group, the discussion will use the Acceptance and Commitment Therapy (ACT) approach and will also last for 45 minutes. The content of the discussion will follow the protocol-based ACT extracted from the protocol for the contextual pain management by physiotherapy being used in INPUT center of St Thomas Hospital, London and physiotherapy informed by acceptance and commitment therapy protocol (PACT) .
Qualification of the intervention provider:
The intervention providers are registered physiotherapist in Hong Kong who had more than 30 years of clinical experience in treating patient with musculoskeletal problem at public physiotherapist outpatient clinic. For the background of ACT training, the physiotherapists had received training for taught course for ACT and had participated in a two-day clinical attachment for the contextual pain management program in INPUT Center at St. Thomas Hospital in London of United Kingdom in 2018. Besides the participation in the local pilot trial for GrExPACT study, they had also participated in the development for the local clinical service team for stratified care and combined the physical and psychological approach in management of high-risk back pain patients since 2015.
Data processing and statistical analysis:
The statistical analysis will be carried out using IBM SPSS version 28 software. The demographically data will be presented by descriptive statistics. For continuous data, it will be presented as mean, standard deviation and range. For categorical data, it will be presented as frequency and percentage. Normality will be first screened by Boxplot, and further assessed by the Shapiro-Wilk test. For the primary and secondary outcomes, two way repeated measure ANOVA will be carried out. For the effect of time, the post hoc test will be carried out for testing the differences of outcome scores for pre-intervention verse immediate after the program; pre-intervention verse at 3 months; and immediate after the program verse at 3 months. For the effect of intervention, post hoc tests at each time point will be carried out when necessary. Significance was set at p < 0.05. Intention-to-treat analysis will be used and missing data will be replaced with data from the nearest previous non-missing data. Effect sizes (Partial eta squared) will also be computed to establish the magnitude of the treatment effects. The effect sizes will interpreted as small (η2=0.01), medium (η2=0.06) or large (η2=0.14).
Clinical significance:
In the management of elderly patient with chronic nonspecific low back pain (LBP), to face the aging population, growing high patient volume and limited resources in health care, an effective and efficient service model is urged. The service model of GrExPACT in the present randomized control trial involve tailor made and resources saving strategy by using concept of stratified care with STarT Back Screening Tool, physical therapy with group exercise and psychological therapy with group ACT lead by physiotherapist. With the present study, the effectiveness, synergistic effect, and adaptability to local culture for combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT) could be studied. The potential positive finding may enhance the role of physiotherapist using the psychological approach in the management of chronic nonspecific LBP and provide evidence support for the proposed more comprehensive, tailor made and resources saving service model of GrExPACT. This may help to reform a more effective and efficient model of care in Hong Kong.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This two-armed randomised controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with PACT (GrExPACT experimental intervention) as compared to Group Exercise (GrEx) alone led by physiotherapist (control intervention) for elderly with chronic LBP
| Arm | Type | Receives |
|---|---|---|
| Group Exercise with acceptance and commitment therapy | Experimental | Behavioral: GrExPACTCombining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT) |
| Group Physiotherapy Exercise alone | Active comparator | Behavioral: GrExGroup Physiotherapy exercise alone (GrEx) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Ages ≥ 65;
- Nonspecific LBP for > 3 month;
- Stratified as medium-risk category (i.e., total score ≥ 4 and sub score ≤ to 3) and high-risk category (i.e., total score ≥ 4 and sub score ≥ 4) using the STarT Back Screening Tool;
- Roland Morris Disability Questionnaire (RMDQ) score ≥ 5 (with reference to the minimal level of detectable change)(30, 31);
- Able to walk with or without assistive aid and with Modified Functional Ambulatory Category ≥ 6 (32);
Key exclusion criteria (8 listed)
- Specific cause of LBP such as tumor, infection, or apparent neurological deficit;
- Serious uncontrolled co-morbidities or systematic diseases which is contraindicated to exercise;
- Orthopedic condition like recent fracture require immobilization and not fitting for exercise;
- Unstable cardiac, pulmonary, metabolic, and psychological disease requiring acute care;
- Severe cognitive, language or hearing deficits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrExPACTAlso: No other intervention (No drug, No device)Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapy | Behavioural | Group Exercise with acceptance and commitment therapy |
| GrExAlso: No other intervention (No drug, No device)Group physiotherapy exercise | Behavioural | Group Physiotherapy Exercise alone |
Primary outcome
Roland Morris Disability Questionnaire
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
The Roland Morris Disability Questionnaire is a 24 self-administrated items scale which measures the level of disability of patients with LBP. Items are yes and no response in which the item will score 0 with negative response and score 1 for positive response. The score for the Roland Morris Disability Questionaire is the sum of scores of the items with positive response. A patient score can range from 0 to 24. The higher the score, the greater is the disability.
7 secondary outcomes
Committed Action Questionnaire
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Chronic Pain Acceptance Questionnaire
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Pain self-efficacy Questionnaire
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Brief Pain Inventory
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Patient Specific Functional Scale
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Short Physical Performance Battery
Time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention
Patient satisfaction Survey
Time frame: immediate post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 27376890Verhagen AP, Downie A, Popal N, Maher C, Koes BW. Red flags presented in current low back pain guidelines: a review. Eur Spine J. 2016 Sep;25(9):2788-802. doi: 10.1007/s00586-016-4684-0. Epub 2016 Jul 4.
- Background: PubMed 27929617National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/
- Background: PubMed 32260488Vadala G, Russo F, De Salvatore S, Cortina G, Albo E, Papalia R, Denaro V. Physical Activity for the Treatment of Chronic Low Back Pain in Elderly Patients: A Systematic Review. J Clin Med. 2020 Apr 5;9(4):1023. doi: 10.3390/jcm9041023.
- Background: PubMed 27257858Straube S, Harden M, Schroder H, Arendacka B, Fan X, Moore RA, Friede T. Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research-systematic review and meta-analysis. Pain. 2016 Oct;157(10):2160-2172. doi: 10.1097/j.pain.0000000000000640.
- BackgroundJacobs, C. (2015). Contextual pain management physiotherapy. NPUT center of St Thomas Hospital London UK.
- Background: PubMed 27267109Godfrey E, Galea Holmes M, Wileman V, McCracken L, Norton S, Moss-Morris R, Pallet J, Sanders D, Barcellona M, Critchley D. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain. BMJ Open. 2016 Jun 7;6(6):e011548. doi: 10.1136/bmjopen-2016-011548.
- Background: PubMed 6222486Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
- BackgroundTsang, R. C. (2004). Measurement properties of the Hong Kong Chinese version of the Roland-Morris disability questionnaire. Hong Kong Physiotherapy Journal, 22(1), 40-49.
- Background: PubMed 23651881McCracken LM. Committed action: an application of the psychological flexibility model to activity patterns in chronic pain. J Pain. 2013 Aug;14(8):828-35. doi: 10.1016/j.jpain.2013.02.009. Epub 2013 May 4.
- Background: PubMed 26214015Wong WS, McCracken L, Wong S, Chen PP, Chow YF, Fielding R. The Chinese version of the 8-item Committed Action Questionnaire (ChCAQ-8): A preliminary analysis of the factorial and criterion validity. Psychol Assess. 2016 Jun;28(6):e111-8. doi: 10.1037/pas0000187. Epub 2015 Jul 27.
- Background: PubMed 18824301Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.
- Background: PubMed 27537558Liu Y, Wang L, Wei Y, Wang X, Xu T, Sun J. Validation of a Chinese version of the Chronic Pain Acceptance Questionnaire (CAPQ) and CPAQ-8 in chronic pain patients. Medicine (Baltimore). 2016 Aug;95(33):e4339. doi: 10.1097/MD.0000000000004339.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Ha Sharon Tsang, Doctor principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GrExPACT and GrEx in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kit Chi Yeung (852 35053239, angelinayeungykc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (time frame: Pre-intervention, immediate post-intervention and 3 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148896, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.