NCT05282589

Brief Summary

The aim of the study is determine the effects of lumbopelvic manipulation on fatigue, pain and disability in chronic low back pain patients. In this randomised clinical trial, lumbopelvic manipulation group was compared with conventional therapy group. Tools used in the study are numeric pain rating scale ,oswestry low back pain index and rating of fatigue scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

September 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 20, 2022

Last Update Submit

March 8, 2022

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Fatigue assessment scale (FAS)

    Among the ten questions of the FAS. Every point of has further five components in which 1 means "never" and 5 means "always". Its scoring is from 10-50 in which 10 showing lowest fatigue level and 50 means indicating highest fatigue level. If the overall score is less than 22 it denotes no fatigue while if the score is more than 22 it will show the presence of substantial fatigue.

    4th week

Secondary Outcomes (3)

  • Numeric pain rating scale (NPRS)

    4th week

  • Oswestry low back pain questionnaire

    4th week

  • Range of Motion

    4th week

Study Arms (2)

Lumbopelvic manipulation and conventiontional therapy

EXPERIMENTAL

Group A an experimental group was given conventional therapy and lumbopelvic manipulation. conventional therapy include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening. while lumbopelvic manipulation include high velocity thrust given in posterior direction to ASIS.

Other: lumbopelvic manipulation and conventional therapy

conventional therapy

ACTIVE COMPARATOR

Group B, control group was given only conventional therapy which include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening . 1 set of 10 repetitions, 3 sessions per week with a total of 12 sessions.

Other: conventional therapy

Interventions

lumbopelvic manipulation and conventional therapyOTHER

Lumbopelvic manipulation was given along with conventional physical therapy Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.

Lumbopelvic manipulation and conventiontional therapy
conventional therapyOTHER

Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.

conventional therapy

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • females patients having fatigue along with chronic low back pain low back pain for more than three months age 20-60

You may not qualify if:

  • patients with conditions other than chronic low back pain having radiculopathy history of serious underlying pathology such as nerve root compromise, structural deformities, genetic spinal disorders and previous spinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46010, Pakistan

Location

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blinded means that the participants have no idea of what treatment they are receiving and to which group they belong.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 16, 2022

Study Start

September 21, 2021

Primary Completion

January 15, 2022

Study Completion

January 28, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)