Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients

Effects Of Lumbopelvic Manipulation On Fatigue In Chronic Low Back Pain Patients

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: lumbopelvic manipulation and conventional therapy; Other: conventional therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46010
      • Pakistan Railway General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbopelvic manipulation and conventiontional therapy; 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; 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.
Active Comparator: conventional therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4th week
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.	4th week
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.	4th week

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Rphah/RCRS/REC/01057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No