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

NCT ID: NCT06707779

Last Updated: 2024-11-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Radiculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PNF with electrical stimulation

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

Group Type EXPERIMENTAL

PNF with electrical stimulation

Intervention Type 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 without electrical stimulation

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

Group Type EXPERIMENTAL

PNF without electrical stimulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PNF with electrical stimulation

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.

Intervention Type OTHER

PNF without electrical stimulation

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arnab Altaf, PP DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University Lahore

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amin welfare and teaching hospital , Awan center

Sialkot, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 38968681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36233636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31713029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32931763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38665744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38440379 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/24/0214 Azka Yaseen

Identifier Type: -

Identifier Source: org_study_id