Low Back PainNCT04975568
Effectiveness of Therapeutic Exercise App Adding a Face-to-face Physical Therapist in Low Back Pain
A study testing App and face-to-face physical therapy and App physical therapy in people with Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- App and face-to-face physical therapy and App physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and ≤ 65 years old.
- Suffering low back pain.
- In a subacute and chronic phase
Who cannot join
- Non signature of the informed consent
- Red Flags are risk factors detected in low back pain patients' past medical history and symptomatology and are associated with a higher risk of serious disorders causing low back pain compared to patients without these characteristics.
- Yellow Flags are psychosocial factors that increase the risk of developing, or perpetuating chronic pain and long-term disability (including) work-loss associated with low back pain.
- Pregnancy and lactation
- Serious trauma or back surgery before the study
- Illness or dysfunction of balance
Show all 10Show fewer
- Visual dysfunction.
- Neurological illness, dysfunction or pain.
- Inability to stand up and sit without help
- Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal instructions (e.g. Illiteracy, dementia or blindness) or read, understand and use an app
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Therapeutic Exercise Controlled Through App Adding Face-to-face Supervision Executed by Physical Therapist in the Subacute and Chronic Low Back Pain
Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms slightly improve.
The value of personalized therapeutic exercised programs in patients suffering LBP has been shown nowadays, improving symptomatology and quality of life.
Read more
New technologies help patients to engage more in treatment, while time that health education make people "active patients".
The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days with a physical therapist .
Read the detailed description
INTRODUCTION
Low back pain is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain . Sub-acute low back pain as low back pain persisting between 6 and 12 weeks; chronic low back pain as low back pain persisting for 12 weeks or more. It is not usual define specific causes of LBP, no more than 15 % patients have a define cause. Non-specific low back pain is defined as low back pain not attributed to recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome).
LBP is one of main world health problems, 23.9 % world citizens suffer LBP over a month in their life. World aging foresee this percentage will increase more in women from 40 to 80 years old. In 2017 LBP was an important men and women chronic health problem in Spain, the second cause more important in women with 23.5 % Spanish women suffering it and the third one in men with 15.8 % Spanish men suffering it. LBP is also the most important cause of work absenteeism with general back pain and migraine.
LBP is related with sedentary lifestyle. Recurrent low back pain is usual. There are several studies searching LBP's risks and LBP's risks factors but they did not show a clear reason.
Studies about app beef up treatment engagement and treatment effectiveness. Last studies about engagement and health improvement using app had shown positive results in diabetes patients, hypertension patients, heart pathology or daily pain management without help (for example Keele Pain Recorder app).
There is a wide and proven evidence of the improvement in symptomatology using app to prescribe exercise in patients suffering LBP according to Sunil et al papers (aerobic daily programs plus 7 specific exercise towards LBP treatment), proposing health mobile apps as an important tool to chronic pathologies.
But in front of the positive situation of a better engagement, app use has a couple of limitations as the reinforcement that a face-to-face control provides ant the information that a specialist health professional can add to the app mobile development to improve the final results.
JUSTIFICATION
LBP is one of the most important health problems of our society. The present study postulates the possible link between technology and real treatment, proposing a HTEP created to non-specific LBP with an app, using McGill's Big Three exercise as the base of the program.
McGill's Big Three Exercise are 3 basic and low complexity exercises to treat any patient who is suffering non-specific low back pain, that had shown a real effectiveness in order to reduce pain intensity and to get better functionality. McGill proposed 3-exercise warm up before the Big Three "Curl up", "Side Bridge" and "Bird Dog" that had to be executed in an isometric contraction. Maximal muscular contraction had to be under 8 seconds, because longer contraction would reduce effectiveness as McGill showed in one of his studies.
The study will propose an individualized McGill Program using an app as support to the two arms of the study, and the main difference will be that experimental group will have a face-to-face control every 15 days and the control group will work only with the app.
App development has the supervision or three specialized physical therapists in LBP.
HYPOTHESIS
The addition of 6 face-to-face sessions executed by physical therapist to the personalized HTEP provided by the app is more effective at improving pain intensity, functionality, quality of life and treatment engagement in patients suffering non-specific LBP.
OBJECTIVES
General:
Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP.
Specifics
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP reducing pain intensity measured by PI-NRS.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving functionality measured by Oswestry scale.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving life quality of life measured by SF-12 scale.
- Evaluate patient satisfaction degree of a semi presential treatment measured by PSQ.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving engagement treatment analyzing app database.
METHODOLOGY
Type of study: randomized and controlled pilot study, in a two arms study with parallel interventions the experimental one and the control one. The study will blind randomization, patient assessment and data analysis. Patient randomization will take place at "Universidad Complutense de Madrid" using random permutations model of Moses and Oakford. Study characteristics itself prevent their blinded application cause:
- Evaluators (baseline, intervention, and post-intervention) will be different professionals that physical therapist will provide face-to-face sessions, and they will ignore in which group patients are in.
- Physical therapist that provide face-to-face sessions will not have any evaluation data.
This study will assure blinded randomization assessment, recruiters and evaluators of assessment group of each patient.
Location: Universidad Complutense de Madrid. Study Subjects: 90 patients suffering non-specific LBP
Sample size: This study has a paper published in 2018 as reference and the standard deviation was 2 in pain measure variable.
Accepting an alpha risk of 0.5 and a beta risk of 0.2 in a two-sided test, 90 subjects (45 in the control group and 45 in the experimental group) are necessary to recognize as statistically significant a difference greater than or equal to 1.5 units. The standard deviation is assumed to be 2, and it has been anticipated a drop-out rate of 10 %.
Data collection and analysis. Before starting the study, all patients will be asked to sign an informed consent in the first session where it will take place the initial assessment including the collection of patient data records and the booklet of questionnaires and clinical measurements using the app.
The patient will receive weekly 3 sessions of his personalized HTEP and experimental group will receive also 6 group session every 15 days t controlled by a physical therapist.
- At first session, before treatment, variables PI-NRS, SF-12 and Oswestry variables will be measured.
- 2 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 4 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.
- 6 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 8 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.
- 10 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 12 weeks after baseline the patient will be re-evaluated. PI-NRS, Oswestry, SF-12, PSQ and engagement variables will be measure The following week to the end of treatment, the patient will be re-evaluated.
The statistical analysis will be performed using SPSS 22.0 program (IBM statistical software).
The average and the standard deviation of quantitative variables will be calculated for the descriptive analysis of the sample. In non-normal distributions the nonparametric sum of the ranges of Wilcoxon and Chi Square test will be performed, as well as the homogeneity in baseline will be displayed by overlapping confidence intervals.
For the comparative analysis, developed according to the intention to treat:
- A MANOVA (ANOVA for repeated measures) test should be carry out to evaluate the interaction between levels of inter - subject factor (treatment) and the intra- subject (main variables response in time) to be interpreted in case it is significant.
- To confirm whether this interaction effect is significant, pairwise comparisons will be made of the inter-subjects factor levels (treatment) for each level of main response variables over time using the Bonferroni method.
Limitations of the study and measures taken to reduce them.
Masking: The nature of the applied treatments prevents masking therapists and patients. This limitation is inherent to the type of treatment evaluated and common with other forms of treatment with similar characteristics, in which therapist should inevitably know the type of treatment that is applied.
However, this limitation does not prevent the controlled clinical trials carried out on these technologies from being of higher methodological quality. Thus, in this study, randomization of patients will be blind, allocation of the random sequence, the assessment of patient evolution and analysis of results.
- Conditions
- Low Back Pain
- Being tested
- App and face-to-face physical therapy, App physical therapy
- Keywords
- Physiotherapy, Mobile Applications, Therapeutic Exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App and face-to-face physical therapyOther
Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. During the app used they will have 6 face-to-face sessions in 6 people groups with a physical Therapist in a 3 months period
App physical therapyOther
Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise Controlled Through App With face-to-face | Experimental | 3 months treatment using app for HTEP and 6 people therapeutic exercise group every 15 days Receives: Other: App and face-to-face physical therapy; Other: App physical therapy |
| Therapeutic Exercise Controlled Through App | Active comparator | 3 months treatment using app for HTEP Receives: Other: App physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale
Intensity of low back pain (measured by Pain Intensity- Numerical Rating Scale ( PI-NRS)) at rest. It will be valued three times with 1 min between the three valuations. 1 item, minimum value 0 and maximum value 10, and 10 is the worse value and the average will be recorded.
Measured: 12 weeks treatment
Secondary outcomes (3)
Number of participants with improve degree of Low Back pain disability based in Oswestry test
Low Back pain disability (measured by Oswestry test). 10 items and 10 points each item, the minimun value is 0 the maximum is 100, and 100 is the worse outcome
Measured: At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment
Number of participants with improve degree of quality of life based in Spanish version of the Short Form Health Survey
Quality of life (measured by a previously validated Spanish version of the Short Form Health Survey (SF-12)) 12 items, the minimun value is 12 the maximum is 55, and 55 is the worse outcome
Measured: At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment
Level of physical therapy intervention satisfaction based in Spanish version of the Patient Satisfaction Questionnaire
Satisfaction (measured by a previously validated Spanish version of the Patient Satisfaction Questionnaire (PSQ)) 13 items, the minimun value is 13 the maximum is 78, and 78 is the worse outcome
Measured: 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Apr 2021
- Primary completion30 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Responsible party
- Sponsor
- Investigators
- Jose Javier Lopez Marcos, Master, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975568
- Sponsor's protocol ID
- CI 19/514-E
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
PubMed 24787228Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169Mesas AE, Gonzalez AD, Mesas CE, de Andrade SM, Magro IS, del Llano J. The association of chronic neck pain, low back pain, and migraine with absenteeism due to health problems in Spanish workers. Spine (Phila Pa 1976). 2014 Jul 1;39(15):1243-53. doi: 10.1097/BRS.0000000000000387.
PubMed 24825151Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Lotzke H, Jakobsson M, Gutke A, Hagstromer M, Brisby H, Hagg O, Smeets R, Lundberg M. Patients with severe low back pain exhibit a low level of physical activity before lumbar fusion surgery: a cross-sectional study. BMC Musculoskelet Disord. 2018 Oct 11;19(1):365. doi: 10.1186/s12891-018-2274-5.
PubMed 30305065da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29.
PubMed 28355981Hanney WJ, Masaracchio M, Liu X, Kolber MJ. The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature. PLoS One. 2016 Jun 10;11(6):e0156799. doi: 10.1371/journal.pone.0156799. eCollection 2016.
PubMed 27285608Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017 Sep;23(9):733-740. doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6.
PubMed 28328396Chao DY, Lin TM, Ma WY. Enhanced Self-Efficacy and Behavioral Changes Among Patients With Diabetes: Cloud-Based Mobile Health Platform and Mobile App Service. JMIR Diabetes. 2019 May 10;4(2):e11017. doi: 10.2196/11017.
PubMed 31094324Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5.
PubMed 30431384Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
PubMed 31167489Bedson J, Hill J, White D, Chen Y, Wathall S, Dent S, Cooke K, van der Windt D. Development and validation of a pain monitoring app for patients with musculoskeletal conditions (The Keele pain recorder feasibility study). BMC Med Inform Decis Mak. 2019 Jan 25;19(1):24. doi: 10.1186/s12911-019-0741-z.
PubMed 30683106Chhabra HS, Sharma S, Verma S. Smartphone app in self-management of chronic low back pain: a randomized controlled trial. Eur Spine J. 2018 Nov;27(11):2862-2874. doi: 10.1007/s00586-018-5788-5. Epub 2018 Oct 15.
PubMed 30324496Machado GC, Pinheiro MB, Lee H, Ahmed OH, Hendrick P, Williams C, Kamper SJ. Smartphone apps for the self-management of low back pain: A systematic review. Best Pract Res Clin Rheumatol. 2016 Dec;30(6):1098-1109. doi: 10.1016/j.berh.2017.04.002. Epub 2017 May 25.
PubMed 29103552Durall CJ, Udermann BE, Johansen DR, Gibson B, Reineke DM, Reuteman P. The effects of preseason trunk muscle training on low-back pain occurrence in women collegiate gymnasts. J Strength Cond Res. 2009 Jan;23(1):86-92. doi: 10.1519/JSC.0b013e31818b93ac.
PubMed 19057402
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Exercise Controlled Through App Adding Face-to-face Supervision Executed by Physical Therapist in the Subacute and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04975568
- Acronym / sponsor ID
- CI 19/514-E
- Conditions
- Low Back Pain
- Keywords
- Physiotherapy, Mobile Applications, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Jul 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.
Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms slightly improve.
The value of personalized therapeutic exercised programs in patients suffering LBP has been shown nowadays, improving symptomatology and quality of life.
New technologies help patients to engage more in treatment, while time that health education make people "active patients".
The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days with a physical therapist .
Detailed description
INTRODUCTION
Low back pain is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain . Sub-acute low back pain as low back pain persisting between 6 and 12 weeks; chronic low back pain as low back pain persisting for 12 weeks or more. It is not usual define specific causes of LBP, no more than 15 % patients have a define cause. Non-specific low back pain is defined as low back pain not attributed to recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome).
LBP is one of main world health problems, 23.9 % world citizens suffer LBP over a month in their life. World aging foresee this percentage will increase more in women from 40 to 80 years old. In 2017 LBP was an important men and women chronic health problem in Spain, the second cause more important in women with 23.5 % Spanish women suffering it and the third one in men with 15.8 % Spanish men suffering it. LBP is also the most important cause of work absenteeism with general back pain and migraine.
LBP is related with sedentary lifestyle. Recurrent low back pain is usual. There are several studies searching LBP's risks and LBP's risks factors but they did not show a clear reason.
Studies about app beef up treatment engagement and treatment effectiveness. Last studies about engagement and health improvement using app had shown positive results in diabetes patients, hypertension patients, heart pathology or daily pain management without help (for example Keele Pain Recorder app).
There is a wide and proven evidence of the improvement in symptomatology using app to prescribe exercise in patients suffering LBP according to Sunil et al papers (aerobic daily programs plus 7 specific exercise towards LBP treatment), proposing health mobile apps as an important tool to chronic pathologies.
But in front of the positive situation of a better engagement, app use has a couple of limitations as the reinforcement that a face-to-face control provides ant the information that a specialist health professional can add to the app mobile development to improve the final results.
JUSTIFICATION
LBP is one of the most important health problems of our society. The present study postulates the possible link between technology and real treatment, proposing a HTEP created to non-specific LBP with an app, using McGill's Big Three exercise as the base of the program.
McGill's Big Three Exercise are 3 basic and low complexity exercises to treat any patient who is suffering non-specific low back pain, that had shown a real effectiveness in order to reduce pain intensity and to get better functionality. McGill proposed 3-exercise warm up before the Big Three "Curl up", "Side Bridge" and "Bird Dog" that had to be executed in an isometric contraction. Maximal muscular contraction had to be under 8 seconds, because longer contraction would reduce effectiveness as McGill showed in one of his studies.
The study will propose an individualized McGill Program using an app as support to the two arms of the study, and the main difference will be that experimental group will have a face-to-face control every 15 days and the control group will work only with the app.
App development has the supervision or three specialized physical therapists in LBP.
HYPOTHESIS
The addition of 6 face-to-face sessions executed by physical therapist to the personalized HTEP provided by the app is more effective at improving pain intensity, functionality, quality of life and treatment engagement in patients suffering non-specific LBP.
OBJECTIVES
General:
Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP.
Specifics
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP reducing pain intensity measured by PI-NRS.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving functionality measured by Oswestry scale.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving life quality of life measured by SF-12 scale.
- Evaluate patient satisfaction degree of a semi presential treatment measured by PSQ.
- Evaluate the effectiveness of adding face-to-face supervision sessions executed by Physical Therapist to a HTEP with an app in people suffering non-specific LBP improving engagement treatment analyzing app database.
METHODOLOGY
Type of study: randomized and controlled pilot study, in a two arms study with parallel interventions the experimental one and the control one. The study will blind randomization, patient assessment and data analysis. Patient randomization will take place at "Universidad Complutense de Madrid" using random permutations model of Moses and Oakford. Study characteristics itself prevent their blinded application cause:
- Evaluators (baseline, intervention, and post-intervention) will be different professionals that physical therapist will provide face-to-face sessions, and they will ignore in which group patients are in.
- Physical therapist that provide face-to-face sessions will not have any evaluation data.
This study will assure blinded randomization assessment, recruiters and evaluators of assessment group of each patient.
Location: Universidad Complutense de Madrid. Study Subjects: 90 patients suffering non-specific LBP
Sample size: This study has a paper published in 2018 as reference and the standard deviation was 2 in pain measure variable.
Accepting an alpha risk of 0.5 and a beta risk of 0.2 in a two-sided test, 90 subjects (45 in the control group and 45 in the experimental group) are necessary to recognize as statistically significant a difference greater than or equal to 1.5 units. The standard deviation is assumed to be 2, and it has been anticipated a drop-out rate of 10 %.
Data collection and analysis. Before starting the study, all patients will be asked to sign an informed consent in the first session where it will take place the initial assessment including the collection of patient data records and the booklet of questionnaires and clinical measurements using the app.
The patient will receive weekly 3 sessions of his personalized HTEP and experimental group will receive also 6 group session every 15 days t controlled by a physical therapist.
- At first session, before treatment, variables PI-NRS, SF-12 and Oswestry variables will be measured.
- 2 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 4 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.
- 6 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 8 weeks after baseline, before treatment, SF-12 and Oswestry variables will be measured.
- 10 weeks after baseline, before treatment, PI-NRS variable will be measured.
- 12 weeks after baseline the patient will be re-evaluated. PI-NRS, Oswestry, SF-12, PSQ and engagement variables will be measure The following week to the end of treatment, the patient will be re-evaluated.
The statistical analysis will be performed using SPSS 22.0 program (IBM statistical software).
The average and the standard deviation of quantitative variables will be calculated for the descriptive analysis of the sample. In non-normal distributions the nonparametric sum of the ranges of Wilcoxon and Chi Square test will be performed, as well as the homogeneity in baseline will be displayed by overlapping confidence intervals.
For the comparative analysis, developed according to the intention to treat:
- A MANOVA (ANOVA for repeated measures) test should be carry out to evaluate the interaction between levels of inter - subject factor (treatment) and the intra- subject (main variables response in time) to be interpreted in case it is significant.
- To confirm whether this interaction effect is significant, pairwise comparisons will be made of the inter-subjects factor levels (treatment) for each level of main response variables over time using the Bonferroni method.
Limitations of the study and measures taken to reduce them.
Masking: The nature of the applied treatments prevents masking therapists and patients. This limitation is inherent to the type of treatment evaluated and common with other forms of treatment with similar characteristics, in which therapist should inevitably know the type of treatment that is applied.
However, this limitation does not prevent the controlled clinical trials carried out on these technologies from being of higher methodological quality. Thus, in this study, randomization of patients will be blind, allocation of the random sequence, the assessment of patient evolution and analysis of results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise Controlled Through App With face-to-face | Experimental | Other: App and face-to-face physical therapy, Other: App physical therapy3 months treatment using app for HTEP and 6 people therapeutic exercise group every 15 days |
| Therapeutic Exercise Controlled Through App | Active comparator | Other: App physical therapy3 months treatment using app for HTEP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 and ≤ 65 years old.
- Suffering low back pain.
- In a subacute and chronic phase
Key exclusion criteria (10 listed)
- Non signature of the informed consent
- Red Flags are risk factors detected in low back pain patients' past medical history and symptomatology and are associated with a higher risk of serious disorders causing low back pain compared to patients without these characteristics.
- Yellow Flags are psychosocial factors that increase the risk of developing, or perpetuating chronic pain and long-term disability (including) work-loss associated with low back pain.
- Pregnancy and lactation
- Serious trauma or back surgery before the study
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 |
|---|---|---|
| App and face-to-face physical therapyPatients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. During the app used they will have 6 face-to-face sessions in 6 people groups with a physical Therapist in a 3 months period | Other | Therapeutic Exercise Controlled Through App With face-to-face |
| App physical therapyPatients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. | Other | Therapeutic Exercise Controlled Through App, Therapeutic Exercise Controlled Through App With face-to-face |
Primary outcome
Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale
Time frame: 12 weeks treatment
Intensity of low back pain (measured by Pain Intensity- Numerical Rating Scale ( PI-NRS)) at rest. It will be valued three times with 1 min between the three valuations. 1 item, minimum value 0 and maximum value 10, and 10 is the worse value and the average will be recorded.
3 secondary outcomes
Number of participants with improve degree of Low Back pain disability based in Oswestry test
Time frame: At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment
Number of participants with improve degree of quality of life based in Spanish version of the Short Form Health Survey
Time frame: At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment
Level of physical therapy intervention satisfaction based in Spanish version of the Patient Satisfaction Questionnaire
Time frame: 12 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 24787228Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
- Background: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
- Background: PubMed 24825151Mesas AE, Gonzalez AD, Mesas CE, de Andrade SM, Magro IS, del Llano J. The association of chronic neck pain, low back pain, and migraine with absenteeism due to health problems in Spanish workers. Spine (Phila Pa 1976). 2014 Jul 1;39(15):1243-53. doi: 10.1097/BRS.0000000000000387.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background: PubMed 30305065Lotzke H, Jakobsson M, Gutke A, Hagstromer M, Brisby H, Hagg O, Smeets R, Lundberg M. Patients with severe low back pain exhibit a low level of physical activity before lumbar fusion surgery: a cross-sectional study. BMC Musculoskelet Disord. 2018 Oct 11;19(1):365. doi: 10.1186/s12891-018-2274-5.
- Background: PubMed 28355981da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29.
- Background: PubMed 27285608Hanney WJ, Masaracchio M, Liu X, Kolber MJ. The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature. PLoS One. 2016 Jun 10;11(6):e0156799. doi: 10.1371/journal.pone.0156799. eCollection 2016.
- Background: PubMed 28328396Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017 Sep;23(9):733-740. doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6.
- Background: PubMed 31094324Chao DY, Lin TM, Ma WY. Enhanced Self-Efficacy and Behavioral Changes Among Patients With Diabetes: Cloud-Based Mobile Health Platform and Mobile App Service. JMIR Diabetes. 2019 May 10;4(2):e11017. doi: 10.2196/11017.
- Background: PubMed 30431384Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5.
- Background: PubMed 31167489Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
- Background: PubMed 30683106Bedson J, Hill J, White D, Chen Y, Wathall S, Dent S, Cooke K, van der Windt D. Development and validation of a pain monitoring app for patients with musculoskeletal conditions (The Keele pain recorder feasibility study). BMC Med Inform Decis Mak. 2019 Jan 25;19(1):24. doi: 10.1186/s12911-019-0741-z.
- Chapter 4. European guidelines for the management of chronic nonspecific low back pain. European Spine Journal : Official Publication of the European Spine SocietyLink provided by the sponsor.
- Instituto nacional de estadística. Mujeres y Hombres en España.Link provided by the sponsor.
- Instituto nacional de estadísticaLink provided by the sponsor.
- Adaptación y validación de un cuestionario para medir la satisfacción del tratamiento de fisioterapia en atención primariaLink provided by the sponsor.
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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.
Jose Javier Lopez Marcos, Master principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App and face-to-face physical therapy and App physical therapy in people with Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
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 10 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: finished, as of the sponsor's last update on 7 Nov 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale (time frame: 12 weeks treatment). 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 NCT04975568, which also lists 21 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 Nov 2022.