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Hamstring TightnessNCT05935163

Immediate Effects of Bowen Technique Versus Dynamic Soft Tissue Mobilization on Hamstrings Tightness in Chronic Non-specific Low Back Pain.

A study testing Conventional therapy for hamstring tightness, Bowen Technique and Dynamic Soft Tissue Mobilization (DSTM): in people with Hamstring Tightness, run by Foundation University Islamabad at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Low back pain (LBP) is leading cause of disability and its burden is growing worldwide with an increasing and ageing of population. Poor flexibility or tightness of hamstring muscle has been associated with low back pain. It is a prominent cause of activity limitations and work absenteeism throughout world. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Hamstring Tightness
What is being tested?
Conventional therapy for hamstring tightness, Bowen Technique and Dynamic Soft Tissue Mobilization (DSTM):
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
1 Jan 2023to 1 Aug 2023
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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The patients aged 18-45 years will be included in the study.
  • Patients with chronic low back pain (more than 3 months) will be included.
  • Both genders.
  • 20 to 40 degrees active knee extension loss with hip in 90 degree flexion
  • Pain Intensity (moderate to severe) NPRS (4-6 intensity)

Who cannot join

  • Individuals who were receiving treatment for their pain with another(medical treatment) at the same time
  • Patients who had undergone vertebral column surgery (less than three months before the time of this study).
  • Patients with the infection, neoplasms, metastasis, rheumatoid arthritis, fractures or inflammatory processes were excluded.
  • Dislocations of lower limb
  • Hypermobility of lower limb joint
  • Hamstrings injuries
  • Nerve lesions of lower limb

Trial locations and contacts

1 site in 1 country.

Maryam Tariq, MS MSKPT contact

+923165360826

marytareq2097@gmail.com

Pakistan1 site, 1 recruiting
  • Fauji Foundation Hospital Department of Rehabilitation

    Rawalpindi, Punjab Province, 46000

    Dr Naureen Tassadaq, MBBS, FCPS

    Recruiting

Other trials in Pakistan

About this study

Low back pain (LBP) is leading cause of disability and its burden is growing worldwide with an increasing and ageing of population. Poor flexibility or tightness of hamstring muscle has been associated with low back pain. It is a prominent cause of activity limitations and work absenteeism throughout world. Hence this study was designed to find out superior form of effective technique on active knee extension and experience of pain and disability in chronic nonspecific low back pain.

Read the detailed description

Low back pain (LBP) is leading cause of disability and it is most leading cause of work absenteeism throughout world. Poor flexibility or tightness of hamstring muscle has been associated with low back pain. Hence this study was designed to find out superior form of effective technique on hamstrings tightness and experience of pain and disability in chronic nonspecific low back pain. This study will also assist to set the foundation for further more studies designing magnificent protocols of treatment for affected population.

Being tested
Conventional therapy for hamstring tightness, Bowen Technique, Dynamic Soft Tissue Mobilization (DSTM):
Keywords
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.

  • Conventional therapy for hamstring tightnessProcedure or surgery

    Conventional Physical therapy will include TENS , hot pack , Hamstring self stretch , Calf self stretching , bridging exercise , piriformis stretch , prone on hands and prone on elbows.

  • Bowen TechniqueProcedure or surgery

    Bowen Technique:

    1. The patient will assume a full prone-lying position on the plinth.
    2. Sequence of short gentle moves will be applied over hamstrings. Firstly, the thumbs will be placed on top of the hamstrings muscle and the tightness is assessed.
    3. Then, the muscle will be hooked by the thumbs from its lateral edge. Then, gentle pressure will be applied to the point of resistance to challenge the muscle in medial direction, as the thumbs will be flattened in medial direction, the muscle will pluck under the thumbs.
    4. First with the thumbs, then will be followed by the fingers. Often, the hands are placed with a distance of inch of space between the thumbs and fingers so that the hands performed the technique on the muscle easily.
    5. The whole procedure will be repeated again. The treatment time for each session will be 20 minutes for each side.
  • Dynamic Soft Tissue Mobilization (DSTM):Procedure or surgery

    1. To access the hamstring muscle group, the subject will be asked to attain prone position and deep longitudinal strokes will be applied to the entire muscle group. Once the specific area of hamstring muscle tightness will be located, the remaining treatment will be limited to this target area.
    2. To execute the dynamic intervention, the subject will be requested to move in the supine position with the hip and knee flexed to 90 degree.
    3. Deep longitudinal strokes will be applied in a distal to proximal direction to the area of hamstring tightness and the leg will be passively moved to knee extension. Five strokes will be applied and 20 seconds of shaking is performed at the completion of this technique.
    4. This treatment will be given for 20 minutes on each side.
Study groups in NCT05935163
Study groupRoleWhat they receive
Group A (Coventional treatment with Bowen Therapy)ExperimentalGroup A will be treated with Bowen Technique in addition to conventional treatment. One session, 45 minutes for technique along with conventional treatment will be given. Technique will be performed for 10 minutes on each limb. The data will be collected at baseline and at 4th week. Follow up will be performed for 4 weeks and 3 sessions will be given each week.
Receives: Procedure: Conventional therapy for hamstring tightness; Procedure: Bowen Technique
Group B (Conventional treatment with DSTM)Active comparatorGroup B will be treated with Dynamic Soft Tissue Mobilizations (DSTM) in addition to conventional treatment. One session, 45 minutes for technique along with conventional treatment will be given. Technique will be performed for 10 minutes on each limb. The data will be collected at baseline and at 4th week. Follow up will be performed for 4 weeks and 3 sessions will be given each week.
Receives: Procedure: Conventional therapy for hamstring tightness; Procedure: Dynamic Soft Tissue Mobilization (DSTM):

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Active knee extension test

    active knee extension test, the participant will be in supine-lying position on the treatment bed. Then, participant will flex the hip to 90° while keeping the contralateral hip and knee extended on plinth. The goniometer's fulcrum will be placed on the lateral condyle of the femur at knee joint. The proximal arm of goniometer placed along with the long axis of femur, while moveable arm aligned in line with lateral malleolus. The subject will then extend the knee actively without any pain and tilting of pelvis.

    Measured: 4 weeks

  2. Active straight leg raise (aSLR)

    The active straight leg raise will be conducted bilaterally three times, and best out of 3 attempts will be recorded. The classic straight leg raise is a complete active test. Each leg is tested individually. When performing the aSLR test, the patient is positioned in supine without a pillow under his/her head. The starting position is described with a distance of 20cm between feet. The patient must rise the leg 20cm from the starting position maintaining the knee in complete extension. The participant will be then asked to rate the difficulty of the task using a 6- point Likert scale. 6-point Likert scale (0= not difficult at all, 1 = minimally difficult, 2 = somewhat difficult, 3= fairly difficult, 4= very difficult, and 5= unable to perform). The test is considered positive when the subjective feeling of fatigue is >3.

    Measured: 4 weeks

  3. The sit-and-reach (SR) tests

    The subjects sat on the flat surface with their head, back, and hips against a wall, knees straight, legs together, and soles of the feet positioned flat against Sit and Reach box. In keeping this position, the subject will be requested to extend the arms with palms down and lightly touch the index fingers together. The finger-to-box distance will be measured as the distance between the fingertips and the point at which the feet contacted to the box. Then, the subjects will be asked to bend forward slowly and reached as far forward as possible while keeping the knees extended and sliding their hands along a measuring scale placed on the box. Throughout the test, examiner will check to ensure that the heels remained at the box and that the knees are fully extended. The 0 cm mark of the measuring scale represent the position of the feet against the box, with larger values for better performance having higher flexibility.

    Measured: 4 weeks

Secondary outcomes (2)
  1. Pain intensity

    Pain status of patients will be assessed using NPRS.

    Measured: 4 Weeks

  2. Disability

    Disability will be assessed using RMDQ.

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start1 Jan 2023
  3. Primary completion15 Jul 2023 (estimated)
  4. Study completion1 Aug 2023 (estimated)

Resources

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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935163
Sponsor's protocol ID
FUI/CTR/2023/10
Status last verified
Jul 2023
First submitted
22 May 2023
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional therapy for hamstring tightness, Bowen Technique and Dynamic Soft Tissue Mobilization (DSTM): in people with Hamstring Tightness, run by Foundation University Islamabad 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 7 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 7 Jul 2023. 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 Maryam Tariq, MS MSKPT (+923165360826, marytareq2097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Active knee extension test (time frame: 4 weeks). The study lists 3 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 7 Jul 2023.

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