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Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
lumbopelvic manipulation and conventional therapy
conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pakistan Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbopelvic manipulation and conventiontional therapy

conventional therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numeric pain rating scale (NPRS)
Numeric pain rating scale is 11 point scale which consists of a straight or linear line running from left to right with a range from 0 -10 in which the digit 0 which lies on the left means no pain while the digit 10 lying on the right means the worst pain.
Oswestry low back pain questionnaire
The oswestry low back pain questionnaire is believed to be specially designed for back related disability in daily life activities in 10 queries with a substitutes for verbal response. Its ranking is from 0-100 in which 0 means there is no disability at time and 100 score means absolutely or entirely disabled.
Range of Motion
It was measured by bubble inclinometer. For taking the ranges of flexion and extension 12th thoracic and 1st sacral vertebrae were taken as the reference points. Two bubble inclinometers were used at the same time in standing position.

Full Information

First Posted
February 20, 2022
Last Updated
March 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05282589
Brief Title
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients
Official Title
Effects Of Lumbopelvic Manipulation On Fatigue In Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Low back pain is an extremely common problem which causes morbidity in adults. It is more likely to occur in individuals around the age 20 to 60, this is partly due to the changes that occurs with aging. It can be acute (less than 12 weeks) or chronic (more than 12 weeks). There are many causes of low back pain one of the most common is the lumber disc herniation. Some of the most serious causes of low back pain include (infection, malignancy, vertebral fracture, cauda equina syndrome and inflammatory disorders such as axial spondyloarthritis). Mostly low backpain can be a result of injury such as muscle strain or sprains due to sudden movements or poor body mechanics while lifting heavy loads. Pain in low back can be the result of infection effecting the bony lumber spine, ligaments around the spine, the spinal cord, nerves and muscles of the spine, internal organs and skin around the spine. Treatment for low back pain falls into three broad categories, multidisciplinary therapy is based on intensive exercises that improves physical function and has modest effects on pain physiotherapy treatment of low back pain includes laser, massage, multidisciplinary rehabilitation and spinal manipulation. Spinal manipulation is a high velocity thrust to a joint beyond its restricted range of movement. Spinal manipulation to lumber spine is a common intervention administered for patients with low back pain. There is limited use of the technique in our society especially finding its effects on fatigue in chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
Participant
Masking Description
single blinded means that the participants have no idea of what treatment they are receiving and to which group they belong.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbopelvic manipulation and conventiontional therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
lumbopelvic manipulation and conventional therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue assessment scale (FAS)
Description
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.
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale is 11 point scale which consists of a straight or linear line running from left to right with a range from 0 -10 in which the digit 0 which lies on the left means no pain while the digit 10 lying on the right means the worst pain.
Time Frame
4th week
Title
Oswestry low back pain questionnaire
Description
The oswestry low back pain questionnaire is believed to be specially designed for back related disability in daily life activities in 10 queries with a substitutes for verbal response. Its ranking is from 0-100 in which 0 means there is no disability at time and 100 score means absolutely or entirely disabled.
Time Frame
4th week
Title
Range of Motion
Description
It was measured by bubble inclinometer. For taking the ranges of flexion and extension 12th thoracic and 1st sacral vertebrae were taken as the reference points. Two bubble inclinometers were used at the same time in standing position.
Time Frame
4th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: females patients having fatigue along with chronic low back pain low back pain for more than three months age 20-60 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46010
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients

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