Pain, ChronicNCT03157544
Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit
A study testing multimodal non-pharmacological Pain Relief Kit in people with Pain, Chronic and Musculoskeletal Pain, run by Sport and Spine Rehab Clinical Research Foundation at 2 sites in United States.
Trial summary
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Musculoskeletal Pain, Low Back Pain
- What is being tested?
- multimodal non-pharmacological Pain Relief Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18 and report experiencing average daily musculoskeletal pain of moderate intensity (>3/10) in the neck or low back for greater than 4 weeks.
Who cannot join
- Report any indication for medical clearance prior to engaging in moderate intensity exercise or if they have any other health limitations to engaging in moderate exercise.
- Additional exclusion criteria are the individual is unable to complete any of the data collection protocols, has previously been diagnosed with schizophrenia, dementia or is mentally incapable of providing informed consent or report a previous allergic reaction to kinesiotape or menthol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sport and Spine Rehab
Fairfax, Virginia, 22030
Sport and Spine Rehab
McLean, Virginia, 22101
About this study
Official title: Complementary Management of Chronic Neck and/or Low Back Pain With a Multimodal Non-pharmacological Pain Relief Kit
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration.
Read the detailed description
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration. A secondary purpose of this study is to determine the effect of the kit on product sales and self-reported disability compared to patients who were not offered the kit.
Study Design: A convenience sample of 30 subjects who report being treated by a health care professional for musculoskeletal pain of an acute episode of chronic neck and/or low back pain which has lasted longer than 4 weeks will be recruited. Following screening for inclusion and exclusion criteria eligible individuals will provide informed consent prior to any data collection taking place. Following providing informed consent, subjects will engage in the baseline data collection protocol. Then after completing baseline data collection all participants will receive the intervention that includes the Pain Relief Kit for 3 weeks. All participants enrolled in the project will complete data collection at 3 data collection points. Baseline data collection will take place following informed consent. The second data collection point will take place one week following baseline data collection (T1) and the third data collection point will take place 3 weeks following baseline data collection (T2). In addition, all participants will provide a daily rating of their pain and documentation of pain management interventions they engaged in from the Pain Relief Kit, over the counter (OTC) treatments \&/or treatments prescribed by a health care provider. This will result in a one group repeated measures design in which eligible participants will be provided with a Pain Relief Kit for 3 weeks.
Analysis: Repeated measures ANOVA will determine if the participants changed on any of the outcome variables over the duration of the project (p<.05). This analysis will be repeated to determine the impact of treatment compliance rates on the outcome variables. Main or interaction effects detected by the R-ANOVA will be explored further through calculated Tukey's post hoc comparisons.
- Conditions
- Pain, Chronic, Musculoskeletal Pain, Low Back Pain, Neck Pain
- Being tested
- multimodal non-pharmacological Pain Relief Kit
- Keywords
- Chronic Neck Pain, Chronic Back Pain, non-pharmacological, pain relief
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal non-pharmacological Pain Relief KitBehavioural
Participants will be told: "No two people have the same kind of pain and that pain management must be individualized to your pain. Thus, we want you to try the four modes of the non-pharmacological interventions included in the kit individually and in combination in order to determine what works best to relieve your pain"
The Pain Relief kit will also include written instructions and materials for three behavioral techniques directed at maintaining compliance with the non-pharmacological interventions. During the review of the Pain Relief Kit with a member of the research staff participants will be informed about the recommended use of the three behavioral techniques including setting goals, working with a buddy and keeping a graph of your progress. This information will also be included in written form in the Pain Relief Kit.
| Study group | Role | What they receive |
|---|---|---|
| Pain Relief Kit | Experimental | Immediately following baseline data collection participants will be given the Pain Relief Kit and instructed about the contents. From this kit, a sample of Biofreeze® and TheraBand® Kinesiology Tape will be applied to the participant. The contents of the Pain Relief Kit will include four modes of non-pharmacological interventions that have been previously demonstrated to relieve musculoskeletal pain. Following Baseline data collection, participants will review the content of the Pain Relief Kit with a member of the research staff. During this review the subject will be informed about the recommended use of all the four modes of the non-pharmacological interventions included in the kit. This information will also be included in written form in the Pain Relief Kit. Receives: Behavioral: multimodal non-pharmacological Pain Relief Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
Measured: 3 (Baseline, 1 week, 3 weeks)
Change in visual analog scale (VAS) of pain at 3 weeks
Measured: 3 (Baseline, 1 week, 3 weeks)
Change in Timed performance of functional tasks at 3 weeks
Measured: 3 (Baseline, 1 week, 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Mar 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157544
- Sponsor's protocol ID
- SSR_Toolkit
- Status last verified
- Jul 2024
- First submitted
- 12 May 2017
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Management of Chronic Neck and/or Low Back Pain With a Multimodal Non-pharmacological Pain Relief Kit
- ClinicalTrials.gov ID
- NCT03157544
- Acronym / sponsor ID
- SSR_Toolkit
- Conditions
- Pain, Chronic, Musculoskeletal Pain, Low Back Pain, Neck Pain
- Keywords
- Chronic Neck Pain, Chronic Back Pain, non-pharmacological, pain relief
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 17 May 2017 (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.
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration.
Detailed description
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration. A secondary purpose of this study is to determine the effect of the kit on product sales and self-reported disability compared to patients who were not offered the kit.
Study Design: A convenience sample of 30 subjects who report being treated by a health care professional for musculoskeletal pain of an acute episode of chronic neck and/or low back pain which has lasted longer than 4 weeks will be recruited. Following screening for inclusion and exclusion criteria eligible individuals will provide informed consent prior to any data collection taking place. Following providing informed consent, subjects will engage in the baseline data collection protocol. Then after completing baseline data collection all participants will receive the intervention that includes the Pain Relief Kit for 3 weeks. All participants enrolled in the project will complete data collection at 3 data collection points. Baseline data collection will take place following informed consent. The second data collection point will take place one week following baseline data collection (T1) and the third data collection point will take place 3 weeks following baseline data collection (T2). In addition, all participants will provide a daily rating of their pain and documentation of pain management interventions they engaged in from the Pain Relief Kit, over the counter (OTC) treatments \&/or treatments prescribed by a health care provider. This will result in a one group repeated measures design in which eligible participants will be provided with a Pain Relief Kit for 3 weeks.
Analysis: Repeated measures ANOVA will determine if the participants changed on any of the outcome variables over the duration of the project (p<.05). This analysis will be repeated to determine the impact of treatment compliance rates on the outcome variables. Main or interaction effects detected by the R-ANOVA will be explored further through calculated Tukey's post hoc comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Relief Kit | Experimental | Behavioral: multimodal non-pharmacological Pain Relief KitImmediately following baseline data collection participants will be given the Pain Relief Kit and instructed about the contents. From this kit, a sample of Biofreeze® and TheraBand® Kinesiology Tape will be applied to the participant. The contents of the Pain Relief Kit will include four modes of non-pharmacological interventions that have been previously demonstrated to relieve musculoskeletal pain. Following Baseline data collection, participants will review the content of the Pain Relief Kit with a member of the research staff. During this review the subject will be informed about the recommended use of all the four modes of the non-pharmacological interventions included in the kit. This information will also be included in written form in the Pain Relief Kit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over age 18 and report experiencing average daily musculoskeletal pain of moderate intensity (>3/10) in the neck or low back for greater than 4 weeks.
Key exclusion criteria (2 listed)
- Report any indication for medical clearance prior to engaging in moderate intensity exercise or if they have any other health limitations to engaging in moderate exercise.
- Additional exclusion criteria are the individual is unable to complete any of the data collection protocols, has previously been diagnosed with schizophrenia, dementia or is mentally incapable of providing informed consent or report a previous allergic reaction to kinesiotape or menthol.
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 |
|---|---|---|
| multimodal non-pharmacological Pain Relief KitParticipants will be told: "No two people have the same kind of pain and that pain management must be individualized to your pain. Thus, we want you to try the four modes of the non-pharmacological interventions included in the kit individually and in combination in order to determine what works best to relieve your pain" The Pain Relief kit will also include written instructions and materials for three behavioral techniques directed at maintaining compliance with the non-pharmacological interventions. During the review of the Pain Relief Kit with a member of the research staff participants will be informed about the recommended use of the three behavioral techniques including setting goals, working with a buddy and keeping a graph of your progress. This information will also be included in written form in the Pain Relief Kit. | Behavioural | Pain Relief Kit |
Primary outcome
Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
Time frame: 3 (Baseline, 1 week, 3 weeks)
Change in visual analog scale (VAS) of pain at 3 weeks
Time frame: 3 (Baseline, 1 week, 3 weeks)
Change in Timed performance of functional tasks at 3 weeks
Time frame: 3 (Baseline, 1 week, 3 weeks)
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal non-pharmacological Pain Relief Kit in people with Pain, Chronic and Musculoskeletal Pain, run by Sport and Spine Rehab Clinical Research Foundation at 2 sites 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 2 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: stopped early, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). 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 in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks (time frame: 3 (Baseline, 1 week, 3 weeks)). The study lists 3 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 2 Aug 2024.