Nonspecific Low Back PainNCT06109116
Effects of Self-myofascial Release on Hamstring Flexibility in Patients With Non Specific Low Back Pain
A study testing Self myofascial release+ Conventional PT and Conventional PT in people with Nonspecific Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this preliminary study suggest the addition of self myofascial release to a therapeutic exercise program in reducing hamstring flexibility and would have additional effects on decreasing pain intensity in individuals with non specific low back pain. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Nonspecific Low Back Pain
- What is being tested?
- Self myofascial release+ Conventional PT and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 1 Feb 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with nonspecific low back pain for at least 3 months.
- >20 degree active knee extension loss with hip in 90 degree of flexion
- NPRS >3
- Patients willing to participate and take treatment.
Who cannot join
- Patients having severe orthopedic, neurological disease
- Patients having specific diagnose cause of low back pain (infection, tumor, lumbar spine fracture, radicular pain, cauda equina syndrome)
- Involvement in regular flexibility yoga program
- Recent(<6 months) lower limb, spinal or soft tissue injuries
- Any integumentary contraindication to MFR
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Internatinal Hospital
Islamabad, Punjab Province, 46000
About this study
The aim of this preliminary study suggest the addition of self myofascial release to a therapeutic exercise program in reducing hamstring flexibility and would have additional effects on decreasing pain intensity in individuals with non specific low back pain.
Read the detailed description
There are different treatments that can affect the facial tissue, but MFR techniques have shown promising effects in reducing pain, improving flexibility and daily activities, these techniques involve specifically guided load long-duration mechanical forces to manipulate the myofascial complex (16). Fascia is part of a body-wide tensional force "transmission system" as facial system is innervated by mechano receptors, that when manual pressure is applied may create a range of response via myofascial pathway by transmitting tensional force and decreasing muscle tension that facilitate movement and reduce pain, However in reviewing the literature, there is still theory and hypothesis in relation to the exact mechanism underlying the efficacy of facial manual therapy Self myofascial release (SMR) works under the same principle as myofascial release technique in which individual use their own body mass to exert pressure on soft tissues by tennis ball to the plantar surface of the foot and is widely used to increase flexibility and range of movement further along the posterior muscles of a proposed anatomy train.
- Conditions
- Nonspecific Low Back Pain
- Being tested
- Self myofascial release+ Conventional PT, Conventional PT
- Keywords
- Hamstring flexibility, Non specific low back pain, Self myofascial release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self myofascial release+ Conventional PTOther
The participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel Conventional PT including Hot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise concentrating on the medial arch for 2 minutes in sitting position,with as much pressure as they could, pushing into discomfort but not pain Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility
Conventional PTOther
Hot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise .
Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins
| Study group | Role | What they receive |
|---|---|---|
| Self myofascial release + Conventional PT | Experimental | The participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel concentrating on the medial arch for 2 minutes in sitting position, with as much pressure as they could, pushing into discomfort but not pain. Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility Conventional PT including Hot pack, Knee to chest exercise, bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise.
. Receives: Other: Self myofascial release+ Conventional PT |
| Conventional PT | Other | Hot pack, Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins Type: Self myofascial release to improve hamstring flexibility Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active knee extension test
Participants were lying supine on couch with both legs extended. The leg not being measured was tied with strip at mid-thigh level and the leg which was being measured was moved to 90 angle of hip flexion now participants were asked to extend knee joint as much as possible and hold for 5 second now measurements were taken by goniometer at knee joint same procedure was repeated for other leg
Measured: 3 weeks
Numeric pain rating scale
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, DPT,DSc PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109116
- Sponsor's protocol ID
- Sana REC-01679
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-myofascial Release on Hamstring Flexibility in Patients With Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06109116
- Acronym / sponsor ID
- Sana REC-01679
- Conditions
- Nonspecific Low Back Pain
- Keywords
- Hamstring flexibility, Non specific low back pain, Self myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 31 Oct 2023 (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 aim of this preliminary study suggest the addition of self myofascial release to a therapeutic exercise program in reducing hamstring flexibility and would have additional effects on decreasing pain intensity in individuals with non specific low back pain.
Detailed description
There are different treatments that can affect the facial tissue, but MFR techniques have shown promising effects in reducing pain, improving flexibility and daily activities, these techniques involve specifically guided load long-duration mechanical forces to manipulate the myofascial complex (16). Fascia is part of a body-wide tensional force "transmission system" as facial system is innervated by mechano receptors, that when manual pressure is applied may create a range of response via myofascial pathway by transmitting tensional force and decreasing muscle tension that facilitate movement and reduce pain, However in reviewing the literature, there is still theory and hypothesis in relation to the exact mechanism underlying the efficacy of facial manual therapy Self myofascial release (SMR) works under the same principle as myofascial release technique in which individual use their own body mass to exert pressure on soft tissues by tennis ball to the plantar surface of the foot and is widely used to increase flexibility and range of movement further along the posterior muscles of a proposed anatomy train.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self myofascial release + Conventional PT | Experimental | Other: Self myofascial release+ Conventional PTThe participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel concentrating on the medial arch for 2 minutes in sitting position, with as much pressure as they could, pushing into discomfort but not pain. Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility Conventional PT including Hot pack, Knee to chest exercise, bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise. . |
| Conventional PT | Other | Other: Conventional PTHot pack, Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins Type: Self myofascial release to improve hamstring flexibility |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with nonspecific low back pain for at least 3 months.
- >20 degree active knee extension loss with hip in 90 degree of flexion
- NPRS >3
- Patients willing to participate and take treatment.
Key exclusion criteria (5 listed)
- Patients having severe orthopedic, neurological disease
- Patients having specific diagnose cause of low back pain (infection, tumor, lumbar spine fracture, radicular pain, cauda equina syndrome)
- Involvement in regular flexibility yoga program
- Recent(<6 months) lower limb, spinal or soft tissue injuries
- Any integumentary contraindication to MFR
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 |
|---|---|---|
| Self myofascial release+ Conventional PTThe participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel Conventional PT including Hot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise concentrating on the medial arch for 2 minutes in sitting position,with as much pressure as they could, pushing into discomfort but not pain Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility | Other | Self myofascial release + Conventional PT |
| Conventional PTHot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise . Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins | Other | Conventional PT |
Primary outcome
Active knee extension test
Time frame: 3 weeks
Participants were lying supine on couch with both legs extended. The leg not being measured was tied with strip at mid-thigh level and the leg which was being measured was moved to 90 angle of hip flexion now participants were asked to extend knee joint as much as possible and hold for 5 second now measurements were taken by goniometer at knee joint same procedure was repeated for other leg
Numeric pain rating scale
Time frame: 3 weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability.
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 5 Mar 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.
Asghar Khan, DPT,DSc PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self myofascial release+ Conventional PT and Conventional PT in people with Nonspecific Low Back Pain, run by Riphah International University 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 4 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 5 Mar 2024. 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?
Active knee extension test (time frame: 3 weeks). The study lists 2 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 5 Mar 2024.