Effects of Primal Reflex Release Technique in Chronic Non-specific Low Back Pain

June 15, 2022 updated by: Riphah International University

Effects of Primal Reflex Release Technique on Pain, Disability and Flexibility in Patients With Chronic Non-specific Low Back Pain

Low back pain is a major disorder which occurs from chronic over use and injury to lumbar musculoskeletal system. Sometimes the source of pain is non-specific leading to pain and spasm due to muscle imbalance. Primal reflex release technique is a novel concept to decrease pain and muscle spasm by resetting reflexes using reciprocal inhibition following the concept of rebooting the Autonomic nervous system. This study aims to determine the effects of primal reflex release technique on pain, flexibility and disability in chronic nonspecific low back pain patients.

This study will be a Randomized Controlled trial and will be conducted at Arif Memorial Hospital in Lahore. A sample size of Total 32 patients will be taken in this study using consecutive sampling technique. Patients will be randomly assigned into two groups.

Group A will be treated by conventional therapy and Group B will be treated by conventional therapy and primal reflex release technique. Numeric Pain Rating Scale and Ronald Morris Disability Questionnaire will be used to evaluate pain and disability respectively. Flexibility of low back, Iliopsoas, hamstring, Piriformis and gastrocnemius will be measured by schober's test, modified Thomas test, Active knee extension test, FAIR test and active dorsiflexion, respectively. The evaluation will be on day 1 as pretreatment values and at 2nd and 4th week as post treatment values respectively. The collected data will be analyzed on SPSS - 25.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Arif Memorial Teaching Hospital
        • Principal Investigator:
          • Aleena Waheed, MSPT-OM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 25-45

  • Both males and females
  • Lower cross syndrome diagnosed by straight leg raise, modified Thomas test, piriformis stretch test.
  • History of LBP for more than 6 weeks before the study, or had on-and-off pain having suffered at least 3 episodes of LBP during the year before the study, each lasting more than a year
  • The diagnosis confirmed on the presence of -pain experienced between the costal margins and the inferior gluteal folds which is influenced by physical activities and postures, usually accompanied by painful limitation of motion‖

Exclusion Criteria:

No recent history of injury to lower limb

  • No experience with surgical treatments for disc herniation, spina bifida, or spinal stenosis,
  • No nerve root compression or no neurological problems.
  • SIJ compression test positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control group (conventional therapy)
Other: Control group (conventional therapy)
Physical therapy will be performed using physical agent modality that include hot pack (15 min), and therapeutic exercises (5 repetition per set, 2 sets each session) therapeutic exercises include spinal extension exercise, prone hip extension exercise, posterior pelvic tilt, cat-camel exercise
EXPERIMENTAL: Primal Reflex release Technique
Other: Control group (conventional therapy)
Physical therapy will be performed using physical agent modality that include hot pack (15 min), and therapeutic exercises (5 repetition per set, 2 sets each session) therapeutic exercises include spinal extension exercise, prone hip extension exercise, posterior pelvic tilt, cat-camel exercise
Other: Primal Reflex release Technique
The SI/Lumbar release Iliopsoas release Piriformis release Hamstring release Gastrocnemius release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: 4 week
Patient level of pain will be evaluated by using the NPRS (0-10 with 0 representing -no pain‖ and 10 the -worst pain‖). Clinometric properties of the NPRS are well established .The NPRS minimal clinically important difference (MCID) is 2 points
4 week
Ronald Morris Disability Questionnaire
Time Frame: 4 weeks
To measure the level of disability caused by CLBP, we will use the Ronald Morris disability questionnaire RMDQ (0-24, with 0 representing no disability and 24 the most disability), which has good internal consistency (Cronbach's alpha =0.83) and test-retest reliability (interclass correlation coefficient= 0.87). Its MCID varies between 1-2 points in patients with minimal disability and 7-8 points in patients with severe disability
4 weeks
Schober's Test
Time Frame: 4 weeks
The schober's test will be used to assess flexibility in the lower back. Schober's test will be applied to assess spinal mobility, with participants standing at maximal spinal flexion. The reference points will be near the fifth lumbar vertebra (between the posterior superior iliac spines) and 10 cm above this point. The test will be considered normal when there is difference of five or more centimeters between standing upright and at maximal spinal flexion
4 weeks
Ankle Knee Extension Test
Time Frame: 4 weeks
The Ankle knee extension test (TTT) will be used to measure hamstring muscle flexibility. In this test, each subject will be in supine position, with a small pillow beneath his head and neck. The knee flexion axis will be marked by a pen and from this point, a line will be drawn to the greater trochanter of the femur and one other line to the external malleolus of the ankle. These lines will be used to measure knee joint angles. The goniometer axis will be on the knee axis and its arm will be along the line drawn on the thigh and the other arm will be along the line drawn on the leg. The subject will be asked to do the active knee extension slowly within 3 s as far as he/she could while the ankle remains in a neutral position. Then, when the active knee extension movement will complete and the subject will attempt to keep this situation for a second, the angle indicated by the goniometer will be extension angle of the knee joint
4 weeks
Modified Thomas Test
Time Frame: 4 weeks
The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility
4 weeks
FAIR (Flexion Adduction internal rotation) Test
Time Frame: 4 weeks
The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility
4 weeks
Active Ankle Dorsiflexion Test
Time Frame: 4 weeks
The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression Of Change
Time Frame: 4 weeks
The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7) (23). This scale is valid and recommended for patients with chronic pain
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2022

Primary Completion (ANTICIPATED)

December 25, 2022

Study Completion (ANTICIPATED)

January 10, 2023

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (ACTUAL)

April 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/22/0131 Aleena

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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