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

NCT05347368 | Unknown

• 1 other identifier: REC/Lhr/22/0131 Aleena
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Low Back pain; Disability; Flexibility; Primal Reflex; Autonomic Nervous system

Outcome Measures

Primary Outcomes (7)

• Numeric Pain Rating Scale

  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

  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

  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

  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

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

  4 weeks

• FAIR (Flexion Adduction internal rotation) Test

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

  4 weeks

• Active Ankle Dorsiflexion Test

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

  4 weeks

Secondary Outcomes (1)

• Patient Global Impression Of Change

  4 weeks

Study Arms (2)

Control group (conventional therapy)

OTHER

Other: Control group (conventional therapy)

Primal Reflex release Technique

EXPERIMENTAL

Other: Control group (conventional therapy); Other: Primal Reflex release Technique

Interventions

Control group (conventional therapy) OTHER

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

Control group (conventional therapy); Primal Reflex release Technique

Primal Reflex release Technique OTHER

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

Primal Reflex release Technique

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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‖

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Arif Memorial Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (10)

• Ghorbanpour A, Azghani MR, Taghipour M, Salahzadeh Z, Ghaderi F, Oskouei AE. Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain. J Phys Ther Sci. 2018 Apr;30(4):481-485. doi: 10.1589/jpts.30.481. Epub 2018 Apr 13.

  PMID: 29706690 BACKGROUND

• Rooh Ul Muazzam M, Abbas S, Abbas S, Rafi MA. Frequency of low back pain in young adults and its relationship with different mattresses. J Pak Med Assoc. 2021 Sep;71(9):2177-2180. doi: 10.47391/JPMA.03-494.

  PMID: 34580510 BACKGROUND

• Ijaz M, Akram M, Ahmad SR, Mirza K, Ali Nadeem F, Thygerson SM. Risk Factors Associated with the Prevalence of Upper and Lower Back Pain in Male Underground Coal Miners in Punjab, Pakistan. Int J Environ Res Public Health. 2020 Jun 9;17(11):4102. doi: 10.3390/ijerph17114102.

  PMID: 32526830 BACKGROUND

• Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.

  PMID: 32000363 BACKGROUND

• Chatchawan U, Jupamatangb U, Chanchitc S, Puntumetakul R, Donpunha W, Yamauchi J. Immediate effects of dynamic sitting exercise on the lower back mobility of sedentary young adults. J Phys Ther Sci. 2015 Nov;27(11):3359-63. doi: 10.1589/jpts.27.3359. Epub 2015 Nov 30.

  PMID: 26696698 BACKGROUND

• Sahin N, Karahan AY, Albayrak I. Effectiveness of physical therapy and exercise on pain and functional status in patients with chronic low back pain: a randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Aug 9;64(1):52-58. doi: 10.5606/tftrd.2018.1238. eCollection 2018 Mar.

  PMID: 31453489 BACKGROUND

• Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.

  PMID: 32669487 BACKGROUND

• Albertin ES, Walters M, May J, Baker RT, Nasypany A, Cheatham S. AN EXPLORATORY CASE SERIES ANALYSIS OF THE USE OF PRIMAL REFLEX RELEASE TECHNIQUE TO IMPROVE SIGNS AND SYMPTOMS OF HAMSTRING STRAIN. Int J Sports Phys Ther. 2020 Apr;15(2):263-273.

  PMID: 32269860 BACKGROUND

• Behennah J, Conway R, Fisher J, Osborne N, Steele J. The relationship between balance performance, lumbar extension strength, trunk extension endurance, and pain in participants with chronic low back pain, and those without. Clin Biomech (Bristol). 2018 Mar;53:22-30. doi: 10.1016/j.clinbiomech.2018.01.023. Epub 2018 Jan 31.

  PMID: 29407352 BACKGROUND

• O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.

  PMID: 31630089 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Saima Zahid, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saima Zahid, PhD*

CONTACT

03334349520; Saima.zahid@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: April 25, 2022
• Primary Completion: December 25, 2022
• Study Completion: January 10, 2023
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)