NCT06109116

Brief Summary

The aim of this preliminary study suggest the addition of self myofascial release to a therapeutic exercise program in reducing hamstring flexibility and would have additional effects on decreasing pain intensity in individuals with non specific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

October 25, 2023

Last Update Submit

March 4, 2024

Conditions

Nonspecific Low Back Pain

Keywords

Hamstring flexibilityNon specific low back painSelf myofascial release

Outcome Measures

Primary Outcomes (2)

  • Active knee extension test

    Participants were lying supine on couch with both legs extended. The leg not being measured was tied with strip at mid-thigh level and the leg which was being measured was moved to 90 angle of hip flexion now participants were asked to extend knee joint as much as possible and hold for 5 second now measurements were taken by goniometer at knee joint same procedure was repeated for other leg

    3 weeks

  • Numeric pain rating scale

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability.

    3 weeks

Study Arms (2)

Self myofascial release + Conventional PT

EXPERIMENTAL

The participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel concentrating on the medial arch for 2 minutes in sitting position, with as much pressure as they could, pushing into discomfort but not pain. Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility Conventional PT including Hot pack, Knee to chest exercise, bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise. .

Other: Self myofascial release+ Conventional PT

Conventional PT

OTHER

Hot pack, Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins Type: Self myofascial release to improve hamstring flexibility

Other: Conventional PT

Interventions

Self myofascial release+ Conventional PTOTHER

The participant will be asked to sit on a chair and feet resting on the ground. A tennis ball is used on the sole of each foot behind the metatarsal heads to the heel Conventional PT including Hot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise concentrating on the medial arch for 2 minutes in sitting position,with as much pressure as they could, pushing into discomfort but not pain Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 35 mins Type: Self myofascial release to improve hamstring flexibility

Self myofascial release + Conventional PT
Conventional PTOTHER

Hot pack,Knee to chest exercise, Bridging exercise, Straight leg raise exercise, Ankle pumping exercise, Superman position exercise . Frequency: 3 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins

Conventional PT

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with nonspecific low back pain for at least 3 months.
  • \>20 degree active knee extension loss with hip in 90 degree of flexion
  • NPRS \>3
  • Patients willing to participate and take treatment.

You may not qualify if:

  • Patients having severe orthopedic, neurological disease
  • Patients having specific diagnose cause of low back pain (infection, tumor, lumbar spine fracture, radicular pain, cauda equina syndrome)
  • Involvement in regular flexibility yoga program
  • Recent(\<6 months) lower limb, spinal or soft tissue injuries
  • Any integumentary contraindication to MFR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Internatinal Hospital

Islamabad, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Asghar Khan, DPT,DSc PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

October 25, 2023

First Posted

October 31, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)