Low Back PainPhase 2NCT02714803
Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
A Phase 2 study testing "Connective tissue massage" and "Conservative applications" and "Classic massage group" and "Conservative applications" in people with Low Back Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment. 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?
- "Connective tissue massage" and "Conservative applications" and "Classic massage group" and "Conservative applications"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Oct 2015
- Phase
- Phase 2
- 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
- Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
- Willing to participate
Who cannot join
- Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
- neurological disease;
- psychiatric disease;
- serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
- pregnant during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk Training and Research Hospital
Ankara, Cankaya, 06800
About this study
Official title: Assistant Professor
The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.
- Conditions
- Low Back Pain
- Being tested
- "Connective tissue massage" and "Conservative applications", "Classic massage group" and "Conservative applications", "Sham massage group" and "Conservative applications"
- 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.
"Connective tissue massage" and "Conservative applications"Behavioural
Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
"Classic massage group" and "Conservative applications"Behavioural
Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
"Sham massage group" and "Conservative applications"Behavioural
Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage group | Experimental | Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied Receives: Behavioral: "Connective tissue massage" and "Conservative applications" |
| Classic massage group | Active comparator | Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied Receives: Behavioral: "Classic massage group" and "Conservative applications" |
| Sham massage group | Sham comparator | Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied Receives: Behavioral: "Sham massage group" and "Conservative applications" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low back pain intensity as measured by Visual Analog Scale
Measured: Change from baseline low back pain intensity at 2 weeks
Secondary outcomes (3)
Change in quality of life as assessed by Short Form-36
Measured: Change from baseline quality of life at 2 weeks
Change in functional statue as assessed by Oswestry Disability Index
Measured: Change from baseline functional statue at 2 weeks
Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale
Measured: Change from baseline psychologic statue at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714803
- Sponsor's protocol ID
- 2015-11/33
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor
- ClinicalTrials.gov ID
- NCT02714803
- Acronym / sponsor ID
- 2015-11/33
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Mar 2016 (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 aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage group | Experimental | Behavioral: "Connective tissue massage" and "Conservative applications"Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied |
| Classic massage group | Active comparator | Behavioral: "Classic massage group" and "Conservative applications"Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied |
| Sham massage group | Sham comparator | Behavioral: "Sham massage group" and "Conservative applications"Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
- Willing to participate
Key exclusion criteria (5 listed)
- Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
- neurological disease;
- psychiatric disease;
- serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
- pregnant during 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 |
|---|---|---|
| "Connective tissue massage" and "Conservative applications"Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks. | Behavioural | Connective tissue massage group |
| "Classic massage group" and "Conservative applications"Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks. | Behavioural | Classic massage group |
| "Sham massage group" and "Conservative applications"Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks. | Behavioural | Sham massage group |
Primary outcome
Change in low back pain intensity as measured by Visual Analog Scale
Time frame: Change from baseline low back pain intensity at 2 weeks
3 secondary outcomes
Change in quality of life as assessed by Short Form-36
Time frame: Change from baseline quality of life at 2 weeks
Change in functional statue as assessed by Oswestry Disability Index
Time frame: Change from baseline functional statue at 2 weeks
Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale
Time frame: Change from baseline psychologic statue at 2 weeks
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 22 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Connective tissue massage" and "Conservative applications" and "Classic massage group" and "Conservative applications" in people with Low Back Pain, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 22 Mar 2016. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 in low back pain intensity as measured by Visual Analog Scale (time frame: Change from baseline low back pain intensity at 2 weeks). 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 22 Mar 2016.