NCT05935163

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

May 22, 2023

Last Update Submit

July 4, 2023

Conditions

Keywords

Low back pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Pain intensity

    4 Weeks

  • Disability

    4 Weeks

Study Arms (2)

Group A (Coventional treatment with Bowen Therapy)

EXPERIMENTAL

Group 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.

Procedure: Conventional therapy for hamstring tightnessProcedure: Bowen Technique

Group B (Conventional treatment with DSTM)

ACTIVE COMPARATOR

Group 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.

Procedure: Conventional therapy for hamstring tightnessProcedure: Dynamic Soft Tissue Mobilization (DSTM):

Interventions

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.

Group A (Coventional treatment with Bowen Therapy)Group B (Conventional treatment with DSTM)

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.

Group A (Coventional treatment with Bowen Therapy)

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.

Group B (Conventional treatment with DSTM)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • to 40 degrees active knee extension loss with hip in 90 degree flexion
  • Pain Intensity (moderate to severe) NPRS (4-6 intensity)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital Department of Rehabilitation

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

July 7, 2023

Study Start

January 1, 2023

Primary Completion

July 15, 2023

Study Completion

August 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations