PNF With and Without Electrical Stimulation in Patients With Chronic Lumbar Radiculopathy

NCT06707779 | Completed

• 1 other identifier: REC/24/0214 Azka Yaseen
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous researches have shown how PNF is been used to treat non specific low back pain, subacromial impingement, cervical radiculopathy and many others. In some studies different techniques like Mckenzie method, spinal mobilization and Mulligan traction other than PNF were being used to treat lumbar radiculopathy. According to researchers knowledge little literature available to see the effectiveness of PNF with electrical stimulation in patients with chronic lumbar radiculopathy. Therefore, the purpose of the current study is to examine the effects of PNF with electrical stimulation in patients with chronic lumbar radiculopathy.

Conditions

Lumbar Radiculopathy

Keywords

pain; disability

Outcome Measures

Primary Outcomes (2)

• pain numeric rating scale

  The pain numeric rating scale is a segmented numeric version of visual analog scale in which a respondent selects a whole number 0 to 10 that reflects the intensity of pain. The 11 point numeric scale ranges from 0 representing no pain and 10 representing extreme pain. Higher scores indicating greater pain intensity. e.g. as bad as you can imagine or worst pain. NPRS takes less than 1 minute to complete and easy to administer and score.

  6th week

• Modified Oswestry disability index

  MODI also known as the Oswestry Low Back Pain Disability Questionnaire, as a very crucial instrument to assess a patient's functional disability over the long term. MODI is a patient completed questionnaire included 10 sections of questions. This tool is effective for persistent severe disability. The MODI domains are the following: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and employment/home making. Each section has six statements that are scored from 0 means minimum degree of difficulties in that activity to 5 means maximum degree of difficulty.

  6th week

Study Arms (2)

PNF with electrical stimulation

EXPERIMENTAL

participants in this arm receive PNF with electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy

Other: PNF with electrical stimulation

PNF without electrical stimulation

EXPERIMENTAL

participants in this arm receive PNF without electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy

Other: PNF without electrical stimulation

Interventions

PNF with electrical stimulation OTHER

Group A receive PNF including combination of isotonic and rhythmic stabilization on trunk with electrical stimulation Participants perform three sets10 repetitions at maximal resistance The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively. In total all PNF exercise will be held for 30 to 45 minutes. 'BURST' TENS (acupuncture-like TENS), characterized by discontinuous stimulation at low frequencies (1-4 Hz), with wave durations of 100-400 ms and high intensities, inducing weak muscle twitches for 10 minutes.

PNF with electrical stimulation

PNF without electrical stimulation OTHER

Group B receive PNF including combination of isotonic and rhythmic stabilization on trunk without electrical stimulation. Participants perform three sets of 10 repetitions at maximal resistance will be provided by the same physiotherapist. The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively. In total all PNF exercise will be held for 30 to 45 minutes.

PNF without electrical stimulation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cases of lumbar radiculopathy
• Either one or both legs affected by radiating pain
• Signs of nerve root compression like paresthesia, numbness, tingling, sharp pain
• Impaired deep tendon reflex(knee jerk, ankle jerk)
• Both male and female
• Radiological evidence of lumbar spondylosis with radiculopathy
• Age group between 40 to 70 years
• Positive SLR test between 45° to 70°
• All subjects with symptoms for duration of more than 6 weeks
• Increase leg pain by coughing and sneezing

You may not qualify if:

• Serious spinal conditions e.g infection, tumor, osteoporosis
• Uncontrolled hypertension
• Severe cognitive impairment
• Other neurological conditions and systemic illness like kidney and visceral diseases
• Vertebral fracture and spondylolisthesis
• Pregnant women
• History of spinal surgery in previous 6 months
• Clinical conditions such as oversensitive skin, patients with cardiac pacemakers where application of TENS is contraindicated

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Amin welfare and teaching hospital , Awan center

Sialkot, Punjab Province, 51310, Pakistan

Location

Related Publications (6)

• Kaya DO, Celenay ST, Secer E, Biceroglu H. Pain intensity, spine structure, and body composition in patients with acute discogenic lumbar radiculopathy. Musculoskelet Sci Pract. 2024 Oct;73:103133. doi: 10.1016/j.msksp.2024.103133. Epub 2024 Jul 2.

  PMID: 38968681 BACKGROUND

• Moustafa IM, Diab AAM, Harrison DE. Does Improvement towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial. J Clin Med. 2022 Sep 29;11(19):5768. doi: 10.3390/jcm11195768.

  PMID: 36233636 BACKGROUND

• Clark R, Weber RP, Kahwati L. Surgical Management of Lumbar Radiculopathy: a Systematic Review. J Gen Intern Med. 2020 Mar;35(3):855-864. doi: 10.1007/s11606-019-05476-8. Epub 2019 Nov 11.

  PMID: 31713029 BACKGROUND

• Ghasabmahaleh SH, Rezasoltani Z, Dadarkhah A, Hamidipanah S, Mofrad RK, Najafi S. Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial. Am J Med. 2021 Jan;134(1):135-141. doi: 10.1016/j.amjmed.2020.08.005. Epub 2020 Sep 13.

  PMID: 32931763 BACKGROUND

• Samant P, Tawde P, Tawde DN. Understanding How Patients With Lumbar Radiculopathy Make Sense of and Cope With Their Symptoms. Cureus. 2024 Mar 26;16(3):e56987. doi: 10.7759/cureus.56987. eCollection 2024 Mar.

  PMID: 38665744 BACKGROUND

• Pojskic M, Bisson E, Oertel J, Takami T, Zygourakis C, Costa F. Lumbar disc herniation: Epidemiology, clinical and radiologic diagnosis WFNS spine committee recommendations. World Neurosurg X. 2024 Feb 20;22:100279. doi: 10.1016/j.wnsx.2024.100279. eCollection 2024 Apr.

  PMID: 38440379 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Pain

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Arnab Altaf, PP DPT

  Riphah International University Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: February 2, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 31, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)