Low Back PainNCT05059496
Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.
A study testing Hamstring stretching with Pressure Biofeedback Unit and Hamstring stretching with out Pressure Biofeedback Unit in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of Hamstring stretching using a pressure Biofeedback unit on muscle length, pain, and functional status in patients with low back pain. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Hamstring stretching with Pressure Biofeedback Unit and Hamstring stretching with out Pressure Biofeedback Unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Oct 2020to 28 Feb 2022
- 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 non-specific low back pain
- Chronic pain > 3 months
- Participants having (ODI) score minimum 20% to 40%
- Participants with hamstrings shorter than 70 degrees bilaterally
- Participants who scored 3 or more than 3 on the Numeric Pain Rating Scale (NPRS)
Who cannot join
- History of fracture and surgery
- Patients with osteoarthritis and spondylolisthesis
- Patients with systemic disease except for diabetes mellitus and hypertension
- Patients with disc herniation and leg length discrepancy
- Pregnant females
- Participants with severe back pain or excessive lumber lordosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province, 46000
Momena Shahzad, MS-OMPT, +92-334-2848148, momena.shahzad@riphah.edu.pk
Maryum Rahim, MS-OMPT*
About this study
To determine the effects of Hamstring stretching using a pressure Biofeedback unit on muscle length, pain, and functional status in patients with low back pain.
Read the detailed description
Several studies have been conducted regarding hamstring stretching with the pelvis anteriorly tilted for treating low back pain but there is very little evidence regarding the use of a pressure biofeedback unit for maintaining anterior pelvic tilt so this study aims to find out whether the hamstring stretching while maintaining anterior pelvic tilt using pressure biofeedback is more effective than hamstring stretching without using pressure biofeedback in patients with low back pain.
- Conditions
- Low Back Pain
- Being tested
- Hamstring stretching with Pressure Biofeedback Unit, Hamstring stretching with out Pressure Biofeedback Unit
- Keywords
- Hamstring length, Low back Pain, Pressure Biofeedback unit
- 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.
Hamstring stretching with Pressure Biofeedback UnitOther
Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching with Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.
Hamstring stretching with out Pressure Biofeedback UnitOther
Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching without Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.
| Study group | Role | What they receive |
|---|---|---|
| Hamstring stretching with Pressure Biofeedback Unit | Experimental | Hot pack, Hamstring stretching with Biofeedback unit, TENS Receives: Other: Hamstring stretching with Pressure Biofeedback Unit |
| Hamstring stretching with out Pressure Biofeedback Unit | Active comparator | Hot pack, Hamstring stretching without Biofeedback unit, TENS Receives: Other: Hamstring stretching with out Pressure Biofeedback Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring Length
Changes from baseline, Hamstring length was measured through Goniometer. Normal value of Active knee extension is 90 degree with 90 degree hip flexion. Values less than 70 degree knee extension represents hamstring tightness.
Measured: 12 days
Secondary outcomes (2)
Pain through NPRS
Changes from baseline, Pain was measured through Numeric pain rating scale. 0 represents "no pain" and 10 "worst pain possible".
Measured: 12 days
Functional Status
Changes from baseline, Functional status was measured through Oswestry Disability Index. 0-20 shows "minimal disability", 21-40 "moderate disability", 41-60 "severe disability", 61-80 "crippled" and 81-100 "bed bound patients".
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start13 Oct 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Momena Shahzad, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059496
- Sponsor's protocol ID
- REC/00854 Maryum Rahim
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.
- ClinicalTrials.gov ID
- NCT05059496
- Acronym / sponsor ID
- REC/00854 Maryum Rahim
- Conditions
- Low Back Pain
- Keywords
- Hamstring length, Low back Pain, Pressure Biofeedback unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 28 Sep 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.
To determine the effects of Hamstring stretching using a pressure Biofeedback unit on muscle length, pain, and functional status in patients with low back pain.
Detailed description
Several studies have been conducted regarding hamstring stretching with the pelvis anteriorly tilted for treating low back pain but there is very little evidence regarding the use of a pressure biofeedback unit for maintaining anterior pelvic tilt so this study aims to find out whether the hamstring stretching while maintaining anterior pelvic tilt using pressure biofeedback is more effective than hamstring stretching without using pressure biofeedback in patients with 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 |
|---|---|---|
| Hamstring stretching with Pressure Biofeedback Unit | Experimental | Other: Hamstring stretching with Pressure Biofeedback UnitHot pack, Hamstring stretching with Biofeedback unit, TENS |
| Hamstring stretching with out Pressure Biofeedback Unit | Active comparator | Other: Hamstring stretching with out Pressure Biofeedback UnitHot pack, Hamstring stretching without Biofeedback unit, TENS |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with non-specific low back pain
- Chronic pain > 3 months
- Participants having (ODI) score minimum 20% to 40%
- Participants with hamstrings shorter than 70 degrees bilaterally
- Participants who scored 3 or more than 3 on the Numeric Pain Rating Scale (NPRS)
Key exclusion criteria (6 listed)
- History of fracture and surgery
- Patients with osteoarthritis and spondylolisthesis
- Patients with systemic disease except for diabetes mellitus and hypertension
- Patients with disc herniation and leg length discrepancy
- Pregnant females
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 |
|---|---|---|
| Hamstring stretching with Pressure Biofeedback UnitHot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching with Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins. | Other | Hamstring stretching with Pressure Biofeedback Unit |
| Hamstring stretching with out Pressure Biofeedback UnitHot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching without Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins. | Other | Hamstring stretching with out Pressure Biofeedback Unit |
Primary outcome
Hamstring Length
Time frame: 12 days
Changes from baseline, Hamstring length was measured through Goniometer. Normal value of Active knee extension is 90 degree with 90 degree hip flexion. Values less than 70 degree knee extension represents hamstring tightness.
2 secondary outcomes
Pain through NPRS
Time frame: 12 days
Functional Status
Time frame: 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
Gross Motor
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
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.
Momena Shahzad, MS-OMPT 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 Hamstring stretching with Pressure Biofeedback Unit and Hamstring stretching with out Pressure Biofeedback Unit in people with 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Momena Shahzad, MS (+92-334-2848148, momena.shahzad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring Length (time frame: 12 days). 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 28 Sep 2021.