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

Chronic Non-specific Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347368
• Other study ID #: REC/Lhr/22/0131 Aleena
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: Saima Zahid, PhD*
• Phone: 03334349520
• Email: Saima.zahid[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 10, 2023
• Est. primary completion date: December 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Non-specific Low Back Pain
• Low Back Pain

Intervention

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
• Primal Reflex release Technique
The SI/Lumbar release Iliopsoas release Piriformis release Hamstring release Gastrocnemius release

Locations

Country	Name	City	State
Pakistan	Arif Memorial Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

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. — View Citation

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, Avon). 2018 Mar;53:22-30. doi: 10.1016/j.clinbiomech.2018.01.023. Epub 2018 Jan 31. — View Citation

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. — View Citation

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. — View Citation

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). pii: E4102. doi: 10.3390/ijerph17114102. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Modified Thomas Test	The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility	4 weeks
Primary	FAIR (Flexion Adduction internal rotation) Test	The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility	4 weeks
Primary	Active Ankle Dorsiflexion Test	The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.	4 weeks
Secondary	Patient Global Impression Of Change	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