Pain, BackNCT04861129
Bowen Therapy for Chronic Non-specific Low Back Pain
A study testing Bowen therapy in people with Pain, Back, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
There is emerging evidence that Bowen Therapy may improve musculoskeletal pain. While it can be an effective treatment strategy to enhance pain modulation; studies on the clinical effect are scarce. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Back
- What is being tested?
- Bowen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Apr 2021to 30 Jun 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages between 18 and 65 years
- a diagnosis of low back pain with onset > 12 weeks based on the evaluation by physician
- average pain intensity score of ≥ 3 on NPRS.
Who cannot join
- they have acute disc prolapse or protusion with neurological sign and symptoms in the past 3-months;
- bacterial spondylitis;
- Rheumatoid arthritis;
- ankylosing spondylitis;
- back pain secondary to bone malignancy
- spinal fracture;
Show all 12Show fewer
- osteoporotic collapse;
- cauda equina compression
- prior spinal surgery;
- psychiatric disorder (e.g. psychosis / delusion);
- current pregnancy
- previous experience with Bowen therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowen Therapy for Chronic Non-specific Low Back Pain: Randomized Controlled Trial
There is emerging evidence that Bowen Therapy may improve musculoskeletal pain. While it can be an effective treatment strategy to enhance pain modulation; studies on the clinical effect are scarce. The aim of this study is to examine the effectiveness of Bowen therapy for people with chronic LBP on measures of pain, function, pain-related self-efficacy, and health related quality of life.
Parallel-group randomized controlled trial (RCT) study will be employed. Pain Catastrophizing Scale (PCS) will be adopted as a screening test upon the randomization. A cutoff of more than 30 points will be used to represents clinically relevant level of catastrophizing.
46 participants with informed consent who meet the eligibility criteria of study are recruited and randomly assigned to one of two groups i.e. Bowen Therapy group and Sham Bowen Conventional Therapy group. Permuted block randomization is applied to control the key confounding variable of catastrophizing which is significantly associated with pain and disability in chronic LBP. Sequentially numbered, opaque, sealed envelopes (SNOSE) is used to ensure the allocation sequence before the group allocation. Double blinding of participants and outcome assessor will be adopted. Measurements are collected at the baseline (Week 0), post-intervention (Week 6) and at a 4-week follow-up (Week 10). The primary outcomes are pain as measured by Percentage of Pain Intensity Difference (PID) and pain relief scale (PRS). The secondary outcomes are measuring the physical functioning, self-efficacy in pain and HRQoL using Owestry Disability Index (ODI), Pain Self-efficacy Questionnaire (PSEQ) and SF-12 (HK) respectively. Intervention is provided weekly for 6 sessions lasting 30-40 minutes per treatment session. The experimental group will receive Bowen therapy according to ISBT Bowen Therapy®. The control group will receive a usual OT therapy with the same number of treatment session, treatment time, including back care advice and functional rehab training.
Read the detailed description
Low back pain (LBP) is one of the most common condition resulting in socioeconomic burden on health care systems. LBP is defined as pain, muscle tension, or stiffness in the area between the lower posterior margin of the rib cage and the horizontal gluteal fold with or without leg pain. Acute LBP is defined as pain that lasts less than 6 weeks, sub-acute LBP lasts for 6 to 12 weeks, and chronic LBP lasts for longer than 12 weeks. Prevalence study in Hong Kong showed that an estimated 57.1% and 42.1% of the population reported of LBP at least once in their life time and at least once within the past year respectively. In the past decades, several multidisciplinary clinical guidelines were developed in Canada, UK and US for the management of LBP which aimed to promote consistent best practice in patient care. All the guidelines recommended exercise therapy as one the strategy in terms of non-pharmacological, non-invasive management. The National Institute for Health and Care Excellence (NICE) guideline suggested that group exercise programme (biomechanical, aerobic, mind-body or a combination of approaches) should be provided for people with single episode or flare-up of LBP with or without sciatica. Whereas manual therapy could be offered only alongside exercise. Both US and Canadian guidelines advocated similar recommendations. However, none of the guidelines were able to specify which forms of manual therapy is superior for the management of chronic LBP. Bowen therapy is a complementary and alternative medicine involving light touch over the fascial, specific muscles, tendons and connective tissues to improve flow of blood, lymph and energy. It is one of the fascial techniques which aims to release the muscle tension, improve pain and restore function. Bowen therapy was named after Tom Bowen (1916-1982) and also known as Bowen Technique, Bowenwork and Bowtech which are interchangeable in the literature. It promotes connective tissues to slide over each other and improve the afferents responses in response to dysfunction. While Bowen therapy can be an effective treatment strategy to enhance pain modulation; studies on the mechanism of action of Bowen therapy and its clinical effect are scarce.
In most instances, the basic Bowen moves are applied using the fingers and thumbs. It involves taking a slack over skin, applying a gentle non-invasive pressure over muscles, tendon and fascia. Other techniques including fast release, gentle stretching, repetitive squeezing will be used according to the therapist's assessment. Bowen therapy could facilitate tissue hydration and recoiling properties of fascia. It was suggested that Bowen moves in slow release can activate various sensory receptors (e.g. Merkel's Discs, Meissner's corpuscles and Free Nerve Endings) and mechanoreceptors (e.g. Golgi tendon organs, Ruffini endings and Interstitial receptors). For the Bowen moves in fast release, Pacini corpuscles can be activated. The activation of various Golgi tendon organs can lower the sympathetic nervous system (SNS) activity. Furthermore, interstitial receptors stimulated by Bowen moves can also lower SNS and increase vagal tone to achieve the deep relaxing effect and reduction of nerve pressure. It is suggested to adopt different treatment technique of approach to target the dysfunction arising from various types of fascia. The deep fasciae and the epymisium are related to adjustment in coordination, proprioception, balance, myofascial pain, and muscle cramps. According to different anatomical locations and fascial tissue, enough pressure with manual deep friction is required in order to reach the deep fasciae and epymisium. It can explain why some Bowen moves (e.g. Hamstring sequence on biceps femoris) using elbow instead of fingers to exert enough pressure on the soft tissue. Yet in most instances, light massage, which can be achieved in most of the basic Bowen moves, are adequate to address the pain caused by superficial fascia. The Bowen moves also follows a planned sequence of stimulation based on the evidence on myofascial continuity. In Bowen therapy session, two-minute pauses are applied between a set of Bowen moves, that muscle spindles are activated upon the stretch on the muscle fibers. It can be explained by the general pain sensitization of nerve pathways commonly found in people with chronic pain, and so two-minute waiting time allows the body to make appropriate adjustments to re-align and balance, through the mediation at the spinal cord and central nervous system.
Although clinical practice implies that Bowen therapy is a useful technique, particularly in relation to improved pain, joint mobility and functional status; there is still little published research in the literature about the clinical effect of Bowen therapy. Moreover, majority of the studies reviewed lack of control group design and methodological issues, including small sample size, poor sampling method, inadequate information of study sample, and lack of standardized measurement tools. More vigorous and stringent research design is warranted for the future research study.
- Conditions
- Pain, Back
- Being tested
- Bowen therapy, Sham Bowen therapy
- Keywords
- Bowen therapy, Fascia, Low back pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowen therapyProcedure or surgery
Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session
Sham Bowen therapyProcedure or surgery
Sham Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session
| Study group | Role | What they receive |
|---|---|---|
| Bowen therapy group | Experimental | The experimental group will receive Bowen therapy according to ISBT Bowen Therapy® (Black \& Murray, 2005). It may include sequences 1, 4, 2, hamstrings (movements 1-6) and sacrum sequences in the prone position, and hamstrings sequence (7-18 movements) and 3 in the supine position,. The sequences may also include Bowen movements in the scalenes, trapezius, all erector spinae, sacro-iliac joint ligaments, gluteus maximus and medius, tensor fasciae latae, and gastrocnemius. The application of Bowen sequences is varied between sessions and participants depending on the presenting functional deficit and treatment response. Receives: Procedure: Bowen therapy |
| Sham Bowen Therapy group | Sham comparator | The control group will receive a sham Bowen therapy with the same number of treatment session, treatment time and rest time, that received in the experimental group. However, it consists of gently placing the hands over the areas just enough to maintain contact for the desired time as required by Bowen Therapy, without applying Bowen movement, which is considered the active principle of this technique. Receives: Procedure: Sham Bowen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Percentage of Pain Intensity
11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)
Measured: Week 6 (compared to Week 0)
Change of Percentage of Pain Intensity
11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)
Measured: Week 10 (compared to Week 0)
Pain relief scale
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
Measured: Week 0
Pain relief scale
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
Measured: Week 6
Pain relief scale
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
Measured: Week 10
Secondary outcomes (9)
Owestry Disability Index
Each section has scored from 0 to 5, with 0 representing "no disability" and 5 representing "greatest disability", yielding a total possible score of 50. Finally the score multiplied by two to obtain the index (Score: 0 to 100).
Measured: Week 0
Owestry Disability Index
Each section has scored from 0 to 5, with 0 representing "no disability" and 5 representing "greatest disability", yielding a total possible score of 50. Finally the score multiplied by two to obtain the index (Score: 0 to 100).
Measured: Week 6
Owestry Disability Index
Each section has scored from 0 to 5, with 0 representing "no disability" and 5 representing "greatest disability", yielding a total possible score of 50. Finally the score multiplied by two to obtain the index (Score: 0 to 100).
Measured: Week 10
Chinese version of Pain Self-efficacy Questionnaire
It comprised of 10 items which was rated on a 7-point scale ranging from 0 equals "not at all confident" to 6 equals "completely confident". The total score is calculated by summing up all the items, yielding a maximum possible score of 60. The higher PSEQ score indicated that patients with higher self-efficacy beliefs on performing activities. (Scoring 0 - 60)
Measured: Week 0
Chinese version of Pain Self-efficacy Questionnaire
It comprised of 10 items which was rated on a 7-point scale ranging from 0 equals "not at all confident" to 6 equals "completely confident". The total score is calculated by summing up all the items, yielding a maximum possible score of 60. The higher PSEQ score indicated that patients with higher self-efficacy beliefs on performing activities. (Scoring 0 - 60)
Measured: Week 6
Chinese version of Pain Self-efficacy Questionnaire
It comprised of 10 items which was rated on a 7-point scale ranging from 0 equals "not at all confident" to 6 equals "completely confident". The total score is calculated by summing up all the items, yielding a maximum possible score of 60. The higher PSEQ score indicated that patients with higher self-efficacy beliefs on performing activities. (Scoring 0 - 60)
Measured: Week 10
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Higher component summary scores indicate better health and better HRQoL. Range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest)
Measured: Week 0
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Higher component summary scores indicate better health and better HRQoL. Range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest)
Measured: Week 6
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Higher component summary scores indicate better health and better HRQoL. Range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest)
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start19 Apr 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital
- Responsible party
- Principal investigator, Andy Shu Kei CHENG, The Hong Kong Polytechnic University
- Investigators
- Andy S.K. Cheng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861129
- Sponsor's protocol ID
- RCT_BT_2021
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowen Therapy for Chronic Non-specific Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04861129
- Acronym / sponsor ID
- RCT_BT_2021
- Conditions
- Pain, Back
- Keywords
- Bowen therapy, Fascia, Low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- United Christian Hospital
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
There is emerging evidence that Bowen Therapy may improve musculoskeletal pain. While it can be an effective treatment strategy to enhance pain modulation; studies on the clinical effect are scarce. The aim of this study is to examine the effectiveness of Bowen therapy for people with chronic LBP on measures of pain, function, pain-related self-efficacy, and health related quality of life.
Parallel-group randomized controlled trial (RCT) study will be employed. Pain Catastrophizing Scale (PCS) will be adopted as a screening test upon the randomization. A cutoff of more than 30 points will be used to represents clinically relevant level of catastrophizing.
46 participants with informed consent who meet the eligibility criteria of study are recruited and randomly assigned to one of two groups i.e. Bowen Therapy group and Sham Bowen Conventional Therapy group. Permuted block randomization is applied to control the key confounding variable of catastrophizing which is significantly associated with pain and disability in chronic LBP. Sequentially numbered, opaque, sealed envelopes (SNOSE) is used to ensure the allocation sequence before the group allocation. Double blinding of participants and outcome assessor will be adopted. Measurements are collected at the baseline (Week 0), post-intervention (Week 6) and at a 4-week follow-up (Week 10). The primary outcomes are pain as measured by Percentage of Pain Intensity Difference (PID) and pain relief scale (PRS). The secondary outcomes are measuring the physical functioning, self-efficacy in pain and HRQoL using Owestry Disability Index (ODI), Pain Self-efficacy Questionnaire (PSEQ) and SF-12 (HK) respectively. Intervention is provided weekly for 6 sessions lasting 30-40 minutes per treatment session. The experimental group will receive Bowen therapy according to ISBT Bowen Therapy®. The control group will receive a usual OT therapy with the same number of treatment session, treatment time, including back care advice and functional rehab training.
Detailed description
Low back pain (LBP) is one of the most common condition resulting in socioeconomic burden on health care systems. LBP is defined as pain, muscle tension, or stiffness in the area between the lower posterior margin of the rib cage and the horizontal gluteal fold with or without leg pain. Acute LBP is defined as pain that lasts less than 6 weeks, sub-acute LBP lasts for 6 to 12 weeks, and chronic LBP lasts for longer than 12 weeks. Prevalence study in Hong Kong showed that an estimated 57.1% and 42.1% of the population reported of LBP at least once in their life time and at least once within the past year respectively. In the past decades, several multidisciplinary clinical guidelines were developed in Canada, UK and US for the management of LBP which aimed to promote consistent best practice in patient care. All the guidelines recommended exercise therapy as one the strategy in terms of non-pharmacological, non-invasive management. The National Institute for Health and Care Excellence (NICE) guideline suggested that group exercise programme (biomechanical, aerobic, mind-body or a combination of approaches) should be provided for people with single episode or flare-up of LBP with or without sciatica. Whereas manual therapy could be offered only alongside exercise. Both US and Canadian guidelines advocated similar recommendations. However, none of the guidelines were able to specify which forms of manual therapy is superior for the management of chronic LBP. Bowen therapy is a complementary and alternative medicine involving light touch over the fascial, specific muscles, tendons and connective tissues to improve flow of blood, lymph and energy. It is one of the fascial techniques which aims to release the muscle tension, improve pain and restore function. Bowen therapy was named after Tom Bowen (1916-1982) and also known as Bowen Technique, Bowenwork and Bowtech which are interchangeable in the literature. It promotes connective tissues to slide over each other and improve the afferents responses in response to dysfunction. While Bowen therapy can be an effective treatment strategy to enhance pain modulation; studies on the mechanism of action of Bowen therapy and its clinical effect are scarce.
In most instances, the basic Bowen moves are applied using the fingers and thumbs. It involves taking a slack over skin, applying a gentle non-invasive pressure over muscles, tendon and fascia. Other techniques including fast release, gentle stretching, repetitive squeezing will be used according to the therapist's assessment. Bowen therapy could facilitate tissue hydration and recoiling properties of fascia. It was suggested that Bowen moves in slow release can activate various sensory receptors (e.g. Merkel's Discs, Meissner's corpuscles and Free Nerve Endings) and mechanoreceptors (e.g. Golgi tendon organs, Ruffini endings and Interstitial receptors). For the Bowen moves in fast release, Pacini corpuscles can be activated. The activation of various Golgi tendon organs can lower the sympathetic nervous system (SNS) activity. Furthermore, interstitial receptors stimulated by Bowen moves can also lower SNS and increase vagal tone to achieve the deep relaxing effect and reduction of nerve pressure. It is suggested to adopt different treatment technique of approach to target the dysfunction arising from various types of fascia. The deep fasciae and the epymisium are related to adjustment in coordination, proprioception, balance, myofascial pain, and muscle cramps. According to different anatomical locations and fascial tissue, enough pressure with manual deep friction is required in order to reach the deep fasciae and epymisium. It can explain why some Bowen moves (e.g. Hamstring sequence on biceps femoris) using elbow instead of fingers to exert enough pressure on the soft tissue. Yet in most instances, light massage, which can be achieved in most of the basic Bowen moves, are adequate to address the pain caused by superficial fascia. The Bowen moves also follows a planned sequence of stimulation based on the evidence on myofascial continuity. In Bowen therapy session, two-minute pauses are applied between a set of Bowen moves, that muscle spindles are activated upon the stretch on the muscle fibers. It can be explained by the general pain sensitization of nerve pathways commonly found in people with chronic pain, and so two-minute waiting time allows the body to make appropriate adjustments to re-align and balance, through the mediation at the spinal cord and central nervous system.
Although clinical practice implies that Bowen therapy is a useful technique, particularly in relation to improved pain, joint mobility and functional status; there is still little published research in the literature about the clinical effect of Bowen therapy. Moreover, majority of the studies reviewed lack of control group design and methodological issues, including small sample size, poor sampling method, inadequate information of study sample, and lack of standardized measurement tools. More vigorous and stringent research design is warranted for the future research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowen therapy group | Experimental | Procedure: Bowen therapyThe experimental group will receive Bowen therapy according to ISBT Bowen Therapy® (Black \& Murray, 2005). It may include sequences 1, 4, 2, hamstrings (movements 1-6) and sacrum sequences in the prone position, and hamstrings sequence (7-18 movements) and 3 in the supine position,. The sequences may also include Bowen movements in the scalenes, trapezius, all erector spinae, sacro-iliac joint ligaments, gluteus maximus and medius, tensor fasciae latae, and gastrocnemius. The application of Bowen sequences is varied between sessions and participants depending on the presenting functional deficit and treatment response. |
| Sham Bowen Therapy group | Sham comparator | Procedure: Sham Bowen therapyThe control group will receive a sham Bowen therapy with the same number of treatment session, treatment time and rest time, that received in the experimental group. However, it consists of gently placing the hands over the areas just enough to maintain contact for the desired time as required by Bowen Therapy, without applying Bowen movement, which is considered the active principle of this technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages between 18 and 65 years
- a diagnosis of low back pain with onset > 12 weeks based on the evaluation by physician
- average pain intensity score of ≥ 3 on NPRS.
Key exclusion criteria (12 listed)
- they have acute disc prolapse or protusion with neurological sign and symptoms in the past 3-months;
- bacterial spondylitis;
- Rheumatoid arthritis;
- ankylosing spondylitis;
- back pain secondary to bone malignancy
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 |
|---|---|---|
| Bowen therapyIntervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session | Procedure or surgery | Bowen therapy group |
| Sham Bowen therapySham Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session | Procedure or surgery | Sham Bowen Therapy group |
Primary outcome
Change of Percentage of Pain Intensity
Time frame: Week 6 (compared to Week 0)
11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)
Change of Percentage of Pain Intensity
Time frame: Week 10 (compared to Week 0)
11-point scale by reporting a number from 0 - 10, with "0' representing "no pain" and "10" representing the "most intense pain imaginable". Therefore, the change in pain intensity is expressed as the percentage of pain intensity difference (%PID), which converts the raw score change to a proportional measure i.e. pain intensity difference between the assessments / Pain NRS at baseline assessment. (Score: 0 - 100%)
Pain relief scale
Time frame: Week 0
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
Pain relief scale
Time frame: Week 6
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
Pain relief scale
Time frame: Week 10
11-point scale with "0" representing "no relief of pain" and "10" representing "completely relieved" to measure the magnitude of change in pain intensity after the treatment. (Score: 0 - 100%)
9 secondary outcomes
Owestry Disability Index
Time frame: Week 0
Owestry Disability Index
Time frame: Week 6
Owestry Disability Index
Time frame: Week 10
Chinese version of Pain Self-efficacy Questionnaire
Time frame: Week 0
Chinese version of Pain Self-efficacy Questionnaire
Time frame: Week 6
Chinese version of Pain Self-efficacy Questionnaire
Time frame: Week 10
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Time frame: Week 0
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Time frame: Week 6
12-item Chinese (Hong Kong) Short Form Health Survey (version 2)
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- 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.
Andy S.K. Cheng, PhD 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 Bowen therapy in people with Pain, Back, 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 3 inclusion and 12 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 27 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Percentage of Pain Intensity (time frame: Week 6 (compared to Week 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2021.