Mechanical Low Back PainNCT04867356
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
A study testing Spinal Stabilization Exercises (SSE) and Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) in people with Mechanical Low Back Pain, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial summary
The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Spinal Stabilization Exercises (SSE) and Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 1 Jun 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male and female
- 20 to 60 years
- chronic mechanical low back pain
Who cannot join
- patients who had any type of injury or fracture which limits rehabilitation
- patients with the symptoms of radiating pain
- who had disc pathology and spinal cord injury
- patients with medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain
Read the detailed description
A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.
The intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Spinal Stabilization Exercises (SSE), Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
- 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.
Spinal Stabilization Exercises (SSE)Other
Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients.
Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc.
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)Other
In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Stabilization Exercises (SSE) | Active comparator | Not described Receives: Other: Spinal Stabilization Exercises (SSE) |
| Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) | Experimental | Not described Receives: Other: Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Jan 2021
- Primary completion30 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867356
- Sponsor's protocol ID
- HERF/REC/2021-1
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04867356
- Acronym / sponsor ID
- HERF/REC/2021-1
- Conditions
- Mechanical Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 30 Apr 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.
The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain
Detailed description
A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.
The intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Stabilization Exercises (SSE) | Active comparator | Other: Spinal Stabilization Exercises (SSE) |
| Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) | Experimental | Other: Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male and female
- 20 to 60 years
- chronic mechanical low back pain
Key exclusion criteria (4 listed)
- patients who had any type of injury or fracture which limits rehabilitation
- patients with the symptoms of radiating pain
- who had disc pathology and spinal cord injury
- patients with medical conditions
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 |
|---|---|---|
| Spinal Stabilization Exercises (SSE)Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients. Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc. | Other | Spinal Stabilization Exercises (SSE) |
| Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session. | Other | Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) |
Primary outcome
Oswestry disability index
Time frame: 2 weeks
The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use
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 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing Spinal Stabilization Exercises (SSE) and Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS) in people with Mechanical Low Back Pain, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
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 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 7 Jul 2021. 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 Pakistan. 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?
Oswestry disability index (time frame: 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 7 Jul 2021.