- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707779
PNF With and Without Electrical Stimulation in Patients With Chronic Lumbar Radiculopathy
Effect of Proprioceptive Neuromuscular Facilitation With and Without Electrical Stimulation on Pain and Functional Disability in Patients With Chronic Lumbar Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan, 51310
- Amin welfare and teaching hospital , Awan center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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. |
|
Experimental: 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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain numeric rating scale
Time Frame: 6th week
|
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
Time Frame: 6th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnab Altaf, PP DPT, Riphah International University Lahore
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/24/0214 Azka Yaseen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Radiculopathy
-
Cairo UniversityCompletedLumbosacral Radiculopathy | Lumbar Radiculopathy Due to Spinal Nerve Compression | Lumbar Disc Prolapse With Radiculopathy | LUMBAR RADICULOPATHYEgypt
-
Providence Medical Technology, Inc.RecruitingRadiculopathy Lumbar | Degenerative Lumbar Disc DiseaseUnited States
-
October 6 UniversityCompleted
-
American University of Beirut Medical CenterQuantel MedicalNot yet recruitingRadiculopathy Lumbar | Disc Disease LumbarLebanon
-
NeuFit - Neurological Fitness and EducationRecruitingRadiculopathy Lumbar | Radiculopathy Sacral | Radiculopathy Multiple SitesUnited States
-
Izmir City HospitalNot yet recruiting
-
Cairo UniversityNot yet recruiting
-
Khyber Medical University PeshawarKMU-Institute of Health Sciences, IslamabadRecruiting
-
Marmara UniversityNot yet recruitingLumbar Disc Herniation | Radiculopathy LumbarTurkey
-
National University of Natural MedicineRecruitingLumbar RadiculopathyUnited States
Clinical Trials on PNF with electrical stimulation
-
University of LahoreCompletedStroke | Pain | Hemiplegia | Foot Drop | Gait, Drop FootPakistan
-
Cardenal Herrera UniversityCompletedHamstring FlexibilitySpain
-
Cardenal Herrera UniversityCompletedHamstring Flexibility | Hamstring Muscle TightnessSpain
-
Shalamar Institute of Health SciencesNot yet recruiting
-
Hebei General HospitalCompletedStress Urinary IncontinenceChina
-
National Rehabilitation Center, Seoul, KoreaUnknown
-
The Hong Kong Polytechnic UniversityCompleted
-
Lahore University of Biological and Applied SciencesRecruitingStroke | Cerebro-vascular AccidentPakistan
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
National Yang Ming UniversityCompleted