Chronic Low Back PainPhase 3NCT02286232
Chronic Low Back Pain Randomized Controlled Trial
A Phase 3 study testing Stretching exercise and Self-care book in people with Chronic Low Back Pain, run by Stamford Hospital at 1 site in United States.
Trial summary
Chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. The YMCA developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Stretching exercise and Self-care book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2018
- Phase
- Phase 3
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults from 18 through 64 years old who have had low back pain on at least half the days over the previous 6 months
Who cannot join
- We will exclude persons whose back pain is attributed to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis.
- Patients with complex conditions will not participate in the study (eg, sciatica, medicolegal issues, or a previous back surgery).
- We will also exclude persons who do not speak English.
- Finally, persons who are unable to attend classes or unwilling to do home practice will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing a Stretching/Exercise Program and Learning About Self-care Practices From a Self-care Book for Chronic Low Back Pain
Chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. The YMCA developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy of a previously popular YMCA stretching exercise program(s) for back pain. The stretching exercise program that will be studied is a collection of all the resources available for the YMCA stretching exercise program(s). The most recent criteria from a National Institutes of Health sponsored Task Force to study chronic low back pain were applied to this study.
Read the detailed description
The study will employ a two arm parallel group stratified controlled trial. Statistics were prospectively formulated to compare outcomes of 60 people who completed the study, 30 participants in each intervention group. Subjects from 18 through 64 years old with low back pain on at least half the days over the previous 6 months will be recruited by the Wilton Family YMCA and New Canaan Community YMCA to participate in the study. The participants within each recruitment cohort will be randomized by a sub-investigator who is a statistician to the two treatment arms in a ratio of 1:1 (stretching exercise experimental arm: self-care book active comparator arm). Seven cohorts will receive the intervention stretching exercise program at the Wilton Family YMCA and New Canaan Community YMCA from January 2015 to December 2017. The stretching exercise program consists of 12 standardized weekly stretching exercise sessions that incrementally increase in duration from 15-30 minutes. Participants who receive the stretching exercise intervention will be asked to practice the identical stretches that they did in class on non-class days and will be given handouts and a companion CD to assist in this. Thirty control subjects will receive a self-care book. All analyses will be conducted assuming intent-to-treat principles using SAS statistical software. All P values and 95% CIs will be 2-sided with statistical significance at the P = 0.05 value.
- Conditions
- Chronic Low Back Pain
- Being tested
- Stretching exercise, Self-care book
- Keywords
- Chronic low back pain, stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exerciseBehavioural
This program begins with 10 stretches/exercises over 15 minutes on the initial class and incrementally increases by 1 stretch/exercise each session for a total of 21 stretches/exercises over 30 minutes on the 12th session. The program is designed to stretch/exercise the major muscle groups, emphasizing the neck and arms, trunk, and legs. In addition to the stretches, each class will include breathing exercises and guided imagery for relaxation. Classes will be taught by Physical Therapists who are trained to lead classes through the protocol.
Self-care bookBehavioural
The Back Pain Helpbook which provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups.
| Study group | Role | What they receive |
|---|---|---|
| Stretching exercise | Experimental | A series of 12 standardized, weekly stretching exercise classes will be held at the Wilton Family YMCA, designed for people with chronic low back pain unaccustomed to stretching. Participants will be asked to practice the identical routine of that week's stretching exercise class on off days and will be given handouts and CD's to assist in this. Receives: Behavioral: Stretching exercise |
| Self-care book | Active comparator | The Back Pain Helpbook (Moore JE, Lorig K, Von Korff M, Gonzalez VM, Laurent DD. The Back Pain Helpbook. Reading, MA: Perseus Books; 1999)provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups. Receives: Behavioral: Self-care book |
What is being measured
The primary outcome is the main question the study is designed to answer.
>=50% improvement in Roland-Morris Disability Questionnaire (RDQ)
RDQ is a widely used health status measure for low back pain. Scale is from 0 (least disability) to 24 (most disability)
Measured: 12 weeks after start of study
Secondary outcomes (3)
>=50% improvement in average pain over previous week from 0-10 scale
0 (no pain) - 10 (worst imaginable pain)
Measured: 12 weeks after start of study
All items derived from PROMIS and STarTBack as suggested by the NIH Task Force
Composite outcomes of parameters of pain, function, and global assessment as recommended by the NIH Task Force on Research Standards for Low Back Pain
Measured: 6, 12, and 24 weeks after start of study
Roland-Morris Disability Questionnaire (RDQ)
Scale is from 0 (least disability) to 24 (most disability)
Measured: 6 and 24 weeks after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stamford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wilton Family YMCA, New Canaan Community YMCA
- Responsible party
- Sponsor
- Investigators
- Marc Brodsky, MD, Principal investigator, Stamford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286232
- Sponsor's protocol ID
- 14-0610.01
- Status last verified
- Sep 2018
- First submitted
- 5 Nov 2014
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing a Stretching/Exercise Program and Learning About Self-care Practices From a Self-care Book for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02286232
- Acronym / sponsor ID
- 14-0610.01
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, stretching exercises
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stamford HospitalUniversity, hospital or other
- Collaborators
- Wilton Family YMCA, New Canaan Community YMCA
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 7 Nov 2014 (estimated)
- 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.
Chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. The YMCA developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy of a previously popular YMCA stretching exercise program(s) for back pain. The stretching exercise program that will be studied is a collection of all the resources available for the YMCA stretching exercise program(s). The most recent criteria from a National Institutes of Health sponsored Task Force to study chronic low back pain were applied to this study.
Detailed description
The study will employ a two arm parallel group stratified controlled trial. Statistics were prospectively formulated to compare outcomes of 60 people who completed the study, 30 participants in each intervention group. Subjects from 18 through 64 years old with low back pain on at least half the days over the previous 6 months will be recruited by the Wilton Family YMCA and New Canaan Community YMCA to participate in the study. The participants within each recruitment cohort will be randomized by a sub-investigator who is a statistician to the two treatment arms in a ratio of 1:1 (stretching exercise experimental arm: self-care book active comparator arm). Seven cohorts will receive the intervention stretching exercise program at the Wilton Family YMCA and New Canaan Community YMCA from January 2015 to December 2017. The stretching exercise program consists of 12 standardized weekly stretching exercise sessions that incrementally increase in duration from 15-30 minutes. Participants who receive the stretching exercise intervention will be asked to practice the identical stretches that they did in class on non-class days and will be given handouts and a companion CD to assist in this. Thirty control subjects will receive a self-care book. All analyses will be conducted assuming intent-to-treat principles using SAS statistical software. All P values and 95% CIs will be 2-sided with statistical significance at the P = 0.05 value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching exercise | Experimental | Behavioral: Stretching exerciseA series of 12 standardized, weekly stretching exercise classes will be held at the Wilton Family YMCA, designed for people with chronic low back pain unaccustomed to stretching. Participants will be asked to practice the identical routine of that week's stretching exercise class on off days and will be given handouts and CD's to assist in this. |
| Self-care book | Active comparator | Behavioral: Self-care bookThe Back Pain Helpbook (Moore JE, Lorig K, Von Korff M, Gonzalez VM, Laurent DD. The Back Pain Helpbook. Reading, MA: Perseus Books; 1999)provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults from 18 through 64 years old who have had low back pain on at least half the days over the previous 6 months
Key exclusion criteria (4 listed)
- We will exclude persons whose back pain is attributed to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis.
- Patients with complex conditions will not participate in the study (eg, sciatica, medicolegal issues, or a previous back surgery).
- We will also exclude persons who do not speak English.
- Finally, persons who are unable to attend classes or unwilling to do home practice will be excluded.
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 |
|---|---|---|
| Stretching exerciseThis program begins with 10 stretches/exercises over 15 minutes on the initial class and incrementally increases by 1 stretch/exercise each session for a total of 21 stretches/exercises over 30 minutes on the 12th session. The program is designed to stretch/exercise the major muscle groups, emphasizing the neck and arms, trunk, and legs. In addition to the stretches, each class will include breathing exercises and guided imagery for relaxation. Classes will be taught by Physical Therapists who are trained to lead classes through the protocol. | Behavioural | Stretching exercise |
| Self-care bookThe Back Pain Helpbook which provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups. | Behavioural | Self-care book |
Primary outcome
>=50% improvement in Roland-Morris Disability Questionnaire (RDQ)
Time frame: 12 weeks after start of study
RDQ is a widely used health status measure for low back pain. Scale is from 0 (least disability) to 24 (most disability)
3 secondary outcomes
>=50% improvement in average pain over previous week from 0-10 scale
Time frame: 12 weeks after start of study
All items derived from PROMIS and STarTBack as suggested by the NIH Task Force
Time frame: 6, 12, and 24 weeks after start of study
Roland-Morris Disability Questionnaire (RDQ)
Time frame: 6 and 24 weeks after start of study
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 24 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
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.
Marc Brodsky, MD principal investigator
Stamford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stretching exercise and Self-care book in people with Chronic Low Back Pain, run by Stamford Hospital at 1 site in United States.
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 1 inclusion and 4 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 24 Sep 2018. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
>=50% improvement in Roland-Morris Disability Questionnaire (RDQ) (time frame: 12 weeks after start of study). 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 24 Sep 2018.