Low Back PainPhase 2/3NCT01973010
Massage Therapy for Chronic Low Back Pain
A Phase 2/3 study testing Massage and Ibuprofen in people with Low Back Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Massage and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Aug 2014
- Phase
- Phase 2/3
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In accordance of the diagnostic criteria of low back pain;
- Age between 20 and 55 years old;
- Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
- No allergy history of hormone drugs Pain medicine;
- volunteer participation and signing an informed consent in writing.
Who cannot join
- Being pregnant or during lactation;
- Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
- Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
- Receiving message therapy in past 3 months for releasing low back pain.
Trial locations and contacts
1 site in 1 country.
China1 site
Acupuncture and Tuina college of Chengdu University of TCM
Chengdu, Sichuan, 610075
About this study
Official title: Phase 1 Study of Massage Therapy for Chronic Low Back Pain
The purpose of this study is to determine whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain.
Read the detailed description
Chronic low back pain is a prevalent condition among adults. Large majority of the population suffer from Chronic low back pain in their lifetime. At present, there is still no standard treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as a complement to conventional treatment. However, its effectiveness is still not convinced. This trial is designed to assess the effectiveness of massage for chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Massage, Ibuprofen
- Keywords
- massage, low back pain
- 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.
MassageOther
Also called Tuina
Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.
IbuprofenDrug
Also called Pain killer
Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | To treat low back pain with massage Receives: Other: Massage |
| Ibuprofen | Active comparator | Medicine control group Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
to assess the recovery of back function
Measured: At baseline, 4th, 6th, 8th week
Secondary outcomes (2)
Japanese Orthopaedic Association Scores
to assess the improvement of back function
Measured: At baseline, 4th, 6th, 8th week
McGill pain questionnaire
To assess the alleviation of pain
Measured: At baseline, 4th, 6th, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanrong Liang, Professor, Principal investigator, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973010
- Sponsor's protocol ID
- 2011SZ0302.1
- Status last verified
- Sep 2014
- First submitted
- 22 Oct 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang M, Feng Y, Pei H, Deng S, Wang M, Xiao X, Zheng H, Lai Z, Chen J, Li X, He X, Liang F. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial. Trials. 2014 Oct 29;15:418. doi: 10.1186/1745-6215-15-418.
PubMed 25352050
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Massage Therapy for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01973010
- Acronym / sponsor ID
- 2011SZ0302.1
- Conditions
- Low Back Pain
- Keywords
- massage, low back pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 31 Oct 2013 (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.
The purpose of this study is to determine whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain.
Detailed description
Chronic low back pain is a prevalent condition among adults. Large majority of the population suffer from Chronic low back pain in their lifetime. At present, there is still no standard treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as a complement to conventional treatment. However, its effectiveness is still not convinced. This trial is designed to assess the effectiveness of massage for chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: MassageTo treat low back pain with massage |
| Ibuprofen | Active comparator | Drug: IbuprofenMedicine control group |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In accordance of the diagnostic criteria of low back pain;
- Age between 20 and 55 years old;
- Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
- No allergy history of hormone drugs Pain medicine;
- volunteer participation and signing an informed consent in writing.
Key exclusion criteria (4 listed)
- Being pregnant or during lactation;
- Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
- Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
- Receiving message therapy in past 3 months for releasing low back pain.
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 |
|---|---|---|
| MassageAlso: TuinaMassage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation. | Other | Massage |
| IbuprofenAlso: Pain killerIbuprofen is an common analgesics which has been widely used in regular control of various pain symptom. | Drug | Ibuprofen |
Primary outcome
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
Time frame: At baseline, 4th, 6th, 8th week
to assess the recovery of back function
2 secondary outcomes
Japanese Orthopaedic Association Scores
Time frame: At baseline, 4th, 6th, 8th week
McGill pain questionnaire
Time frame: At baseline, 4th, 6th, 8th week
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 9 Sep 2014.
- Derived from this study: PubMed 25352050Yang M, Feng Y, Pei H, Deng S, Wang M, Xiao X, Zheng H, Lai Z, Chen J, Li X, He X, Liang F. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial. Trials. 2014 Oct 29;15:418. doi: 10.1186/1745-6215-15-418.
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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.
Fanrong Liang, Professor principal investigator
Chengdu University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Massage and Ibuprofen in people with Low Back Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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 5 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 9 Sep 2014. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months (time frame: At baseline, 4th, 6th, 8th week). 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 NCT01973010, which also lists 1 linked publication.
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 9 Sep 2014.