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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05935163
Other study ID # FUI/CTR/2023/10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date August 1, 2023

Study information

Verified date July 2023
Source Foundation University Islamabad
Contact Maryam Tariq, MS MSKPT
Phone +923165360826
Email marytareq2097@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date August 1, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional therapy for hamstring tightness
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 Technique
Bowen Technique: The patient will assume a full prone-lying position on the plinth. 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. 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. 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. 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):
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. 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. 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. This treatment will be given for 20 minutes on each side.

Locations

Country Name City State
Pakistan Fauji Foundation Hospital Department of Rehabilitation Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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. 4 weeks
Primary 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. 4 weeks
Secondary Pain intensity Pain status of patients will be assessed using NPRS. 4 Weeks
Secondary Disability Disability will be assessed using RMDQ. 4 Weeks
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