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

Not Applicable
Conditions
Chronic Non-specific Low Back Pain
Interventions
Other: Control group (conventional therapy)
Other: Primal Reflex release Technique
Registration Number
NCT05347368
Lead Sponsor
Riphah International University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
28
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‖
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Primal Reflex release TechniqueControl group (conventional therapy)-
Control group (conventional therapy)Control group (conventional therapy)-
Primal Reflex release TechniquePrimal Reflex release Technique-
Primary Outcome Measures
NameTimeMethod
Numeric Pain Rating Scale4 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 Questionnaire4 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

Ankle Knee Extension Test4 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

FAIR (Flexion Adduction internal rotation) Test4 weeks

The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility

Modified Thomas Test4 weeks

The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility

Schober's Test4 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

Active Ankle Dorsiflexion Test4 weeks

The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.

Secondary Outcome Measures
NameTimeMethod
Patient Global Impression Of Change4 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

Trial Locations

Locations (1)

Arif Memorial Teaching Hospital

🇵🇰

Lahore, Punjab, Pakistan

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