NCT04760366

Brief Summary

The purpose of this study is to assess and evaluate tight iliopsoas muscle in patients with chronic low back pain and to increase hip flexor flexibility in the patients with chronic low back pain by using the technique of manual fascial-muscular lengthening therapy .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 13, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

February 16, 2021

Last Update Submit

September 17, 2021

Conditions

Keywords

FMLTChronic LWPROMODINPRS

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    This scale will be used for assessing low back pain before and after treatment.0 no pain 1-4 mild pain 5-7 moderate and 8-10 sever pain. Baseline,6th day

    6th day

  • For disability: Oswestry Disability Index (ODI)

    Tool used to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). The ODI score is recommended as a back pain-specific measure of disability. Reliability with ICC= 0.85 and validity=0.77 Baseline,6th day

    6th day

  • For tight iliopsoas: Thomas Test.

    This test is used to test the flexibility of hip flexors.Baseline,6th day

    6th day

Study Arms (2)

Group A (Experimental)

EXPERIMENTAL

Patients in this group will receive interventional therapy through fascial- muscular lengthening therapy .Patients in this group will also receive the conventional therapy

Other: fascial- muscular lengthening therapyOther: the conventional therapy

Group B: Conventional treatment

OTHER

Patients in this group will receive the conventional therapy

Other: Stretching's of iliopsoas muscleOther: the conventional therapy

Interventions

Patients in this group will receive interventional therapy To perform this technique: 1. Have the patient in side lying position 2. Hip is maximally flexed to shorten the iliopsoas muscle. 3. Therapist fingers should be on to the targeted area. 4. Apply gentle pressure in upward direction. 5. While maintain the pressure, stretch the muscle by moving the hip in extension through full ROM. 6. Therapist will maintain the pressure in opposing direction. This is considered as one pass. This technique is performed bilaterally. Patients in this group will also receive the conventional therapy which will include: * Hot pack for 15 minutes. * Myofascial release of iliopsoas. * TENS for 15 minutes.

Group A (Experimental)

Patients in this group will receive the interventional therapy which will include: Stretching's of iliopsoas muscle which can be done in two positions: 1. modified lunge position. 2. The prone stretch. Patients in this group will also receive the conventional therapy which will include: * Hot pack for 15 minutes. * Myofascial release of iliopsoas * TENS for 15 minutes.

Group B: Conventional treatment

the conventional therapy

Group A (Experimental)Group B: Conventional treatment

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details• The study includes female patients with chronic low back pain
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The study includes female patients with chronic low back pain.
  • The study includes patients from the age group of 25 years and 45.
  • The study includes patients with low back pain for more than 3 months.
  • The study includes patients with chronic bilateral tight hip flexors which will assessed through Thomas Test
  • Pain in flexion bias

You may not qualify if:

  • The study excludes male patients.
  • No history of serious underlying pathology, nerve root compromise, structural deformities, genetic spinal disorders or previous spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral,Pakistan, 440000, Pakistan

Location

Study Officials

  • Shafaq Shahid, MSPT-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

August 13, 2020

Primary Completion

March 20, 2021

Study Completion

March 20, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations