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

July 4, 2023 updated by: Foundation University Islamabad
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Recruiting
        • Fauji Foundation Hospital Department of Rehabilitation
        • Contact:
          • Dr Naureen Tassadaq, MBBS, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A (Coventional treatment with Bowen Therapy)
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 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.
Procedure: Bowen Technique

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.
Active Comparator: Group B (Conventional treatment with DSTM)
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 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.
Procedure: Dynamic Soft Tissue Mobilization (DSTM):
  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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Active knee extension test
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 Weeks
Pain status of patients will be assessed using NPRS.
4 Weeks
Disability
Time Frame: 4 Weeks
Disability will be assessed using RMDQ.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2023/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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