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NCT Number: NCT05282589

Lumbopelvic Manipulation Effects 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.

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Key information

Conditions

Chronic Low Back Pain

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46010, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lumbopelvic manipulation and conventional therapy

Other

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.

Conventional Therapy

Other

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 outcomes

  1. Fatigue assessment scale (FAS)

    Time frame: 4th week

    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 outcomes

  1. Numeric pain rating scale (NPRS)

    Time frame: 4th week

    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.

  2. Oswestry low back pain questionnaire

    Time frame: 4th week

    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.

  3. Range of Motion

    Time frame: 4th week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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