NCT06017804

Brief Summary

Pain in the lower back is a major concern in today's era due to prolonged sitting in two-wheeler riders, mainly due to hamstring tightness. It also creates physical disability and impairment in activities of daily living. This study aimed to compare the efficacy of muscle energy technique (MET) and self-myofascial release (SMFR) using the foam roller on hamstring flexibility, dynamic balance, and physical disability amongst two-wheeler riders with chronic low back pain. Participants were randomized into two intervention groups, MET and SMFR, using the envelope method, with each group having 20 participants. Hamstring flexibility and range of motion for knee extension and the lower back were assessed using the active knee extension test and sit and reach test, the dynamic balance was assessed by the star excursion balance test (SEBT) and physical disability by Roland-Morris Disability Questionnaire, (RMDQ). Measurements were taken at baseline and after 4-week of intervention. The level of significance value was set at 95% (p \<0.05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 24, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

Hamstring flexibilityMuscle Energy techniqueSelf-myofascial releaseFoam rollerDynamic balancePhysical disabilitySit and reach testActive knee extension

Outcome Measures

Primary Outcomes (4)

  • Hamstring flexibility

    Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.

    4 weeks

  • Active range of motion

    Active range of motion was assessed using a sit and reach test (SRT) at baseline and four weeks post-intervention.

    4 weeks

  • Dynamic balance

    Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.

    4 weeks

  • Roland-Morris Disability Questionnaire Scale

    Roland-Morris Disability Questionnaire (RMDQ) was used assessing the physical disability at baseline and four weeks post-intervention. The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.

    4 weeks

Study Arms (2)

MET Group

EXPERIMENTAL

Received a muscle energy technique

Other: Muscle energy technique

SMFR Group

ACTIVE COMPARATOR

Received a self-myofascial release technique using a foam roller

Other: Self-myofascial release technique

Interventions

Participants were required to adopt a supine position. MET's post-isometric relaxation method was chosen. The therapist gently flexed the patient's hip until the limitation bar-rier was detected. At this stage, isometric contractions against resistance were applied. After that, the patients were told to resist the movement with only 25% of their strength. Before the leg was released, the contraction was maintained for 7-10 seconds. On exhale, the knee joint was straightened (extended) towards its new barrier, and a stretch was applied and maintained through that barrier for 30 seconds. This procedure was carried out six times.

MET Group

A foam roller was rolled from the ischial tuberosity to the back of the knee on the side being tested while the participant remained seated in a long sitting position. Individuals were instructed to keep all of their body weight on the leg being evaluated. They spent 30-40 seconds rolling one hamstring at a time in each set (10 times back and forth).

SMFR Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Two-wheeler riders of either gender between the ages of 20 and 40 years,
  • Who had ridden at least two hours per day for the previous two years,
  • Had musculoskeletal pain in the back for the previous three months, and
  • Had a 15-20-degree loss of knee extension when hips were held in 90-degree flexion.

You may not qualify if:

  • Pregnant women,
  • Those with a recent spine or lower limb fracture, recent surgery,
  • A previous hamstring injury,
  • Lumbar and lower limb neurological deficits, or limb length disparity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University

Riyadh, 11433, Saudi Arabia

Location

Study Officials

  • AMIR IQBAL, MPT

    King Saud University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

March 14, 2022

Primary Completion

September 23, 2022

Study Completion

November 29, 2022

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations