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

NCT ID: NCT05347368

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-01-10

Brief Summary

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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

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Conditions

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Chronic Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group (conventional therapy)

Group Type OTHER

Control group (conventional therapy)

Intervention Type 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

Primal Reflex release Technique

Group Type EXPERIMENTAL

Control group (conventional therapy)

Intervention Type 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

Primal Reflex release Technique

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Primal Reflex release Technique

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saima Zahid, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Arif Memorial Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Saima Zahid, PhD*

Role: CONTACT

03334349520

Facility Contacts

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Saima Zahid, PhD*

Role: primary

03334349520

References

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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.

Reference Type BACKGROUND
PMID: 29706690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34580510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32526830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32000363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26696698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31453489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32669487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32269860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29407352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31630089 (View on PubMed)

Other Identifiers

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REC/Lhr/22/0131 Aleena

Identifier Type: -

Identifier Source: org_study_id

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