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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05347368

Collaborator

(none)

Enrollment

Location

Arms

8.5

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Non-specific Low Back Pain	Other: Control group (conventional therapy) Other: Primal Reflex release Technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Dec 25, 2022

Anticipated Study Completion Date :

Jan 10, 2023

Arms and Interventions

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

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)

Other: Primal Reflex release Technique

The SI/Lumbar release Iliopsoas release Piriformis release Hamstring release Gastrocnemius release

Outcome Measures

Primary Outcome Measures

Numeric Pain Rating Scale [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
Ronald Morris Disability Questionnaire [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
Schober's Test [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
Ankle Knee Extension Test [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
Modified Thomas Test [4 weeks]
The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility
FAIR (Flexion Adduction internal rotation) Test [4 weeks]
The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility
Active Ankle Dorsiflexion Test [4 weeks]
The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.

Secondary Outcome Measures

Patient Global Impression Of Change [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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