- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922228
Effects of Neural Flossing and PNF on Lumbar Radiculopathy
Effects of Neural Flossing With and Without Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Disability in Patients With Lumbar Radiculopathy.
Study Overview
Status
Conditions
Detailed Description
Lumbar radiculopathy is a mutual condition amongst persons presenting to a spinal physician for consultation. Lumbar radiculopathy is a term used to describe the pain that is started in low back and radiated along the nerve root. The patient mostly complains from a low back pain that radiates toward the legs. Symptoms may include radiating pain, weakness, hypo-reflexia and gait abnormalities. The pain is caused by the neurological manifestations of a compressive force along a specific nerve route. The main cause of radiculopathy is compression or irritation of nerve root exited from spinal cord. Lumbar radiculopathy can affect anyone regardless of their age, gender, race and geographical locality. About 40% people developed low back pain at some points in their life and out of them 3-5% population developed lumbar radiculopathy.
A study conducted to find out the influence of nerve flossing technique on acute sciatica and hip range of motion with sample size of 32. It was concluded that as a result of nerve flossing technique since no statistically significant changes occurred between the two groups. Hence, for effective reduction of sciatic pain and possible improvement in hip range of motion, nerve flossing technique should be combined with conventional physiotherapy. A study conducted on mobilization of Neurodynamic system using proprioceptive neuromuscular facilitation (PNF) decrease pain and increase mobility in lower extremities and spine suggested that PNF based rehabilitation approach results in improvement of pain, nerve mobility and balance.it also has positive effects by supplying oxygen to nerve, increase nerve mobility and decrease pain.
Some studies have been done testing the effects of neural flossing technique and PNF techniques individually as a treatment option for lumbar radiculopathy. But, up to the researcher's knowledge there is little literature on comparing both treatments with respect to pain, range of motion and disability in lumbar radiculopathy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wajiha Shahid, PhD
- Phone Number: 03214885079
- Email: wajiha.shahid@riphah.edu.pk
Study Locations
-
-
Punjab
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Gujrāt, Punjab, Pakistan, 50700
- Recruiting
- Aziz Bhatti Shaheed Teaching Hospital
-
Contact:
- Wajiha Shahid, PhD
- Phone Number: 03214885079
- Email: wajiha.shahid@riphah.edu.pk
-
Principal Investigator:
- atif chaudhary, MS-NMPT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 35-50 years.
- Both males and females.
- Pain intensity is 4 out of 10 on numeric pain rating scale.
- History of radiculopathy for more than 3 weeks.
- Pain radiating below to knee.
Exclusion Criteria:
- Cognitive impairment.
- Using pain modulating medicines.
- Patients with comorbidities.
- Pain radiating above to knee.
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: Neural flossing with proprioceptive neuromuscular facilitation
nerve flossing technique protocol along with contract relax technique of proprioceptive neuromuscular facilitation is used
|
neural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week contract relax technique of proprioceptive neuromuscular facilitation for 5 minutes, 10 repetitions ×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 10 minutes
|
|
Active Comparator: Neural flossing without proprioceptive neuromuscular facilitation
only nerve flossing technique protocol is used
|
neural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 5 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 5 weeks
|
It is a common pain screening tool use to assess the severity of pain at moment time.
It is 0-10 scale where 0 means no pain and 10 means worst pain imaginable.
|
5 weeks
|
|
Goniometer
Time Frame: 5 weeks
|
It is an instrument used to measure the available range of motion at joints.
It is most commonly used tool to measure the range of motion of joints by physiotherapists.
|
5 weeks
|
|
Oswestry Disability Index (ODI)
Time Frame: 5 weeks
|
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting.
It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Each section is scored on a 0-5 scale, 5 representing the greatest disability.
|
5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajiha Shahid, PhD, Riphah International University
Publications and helpful links
General Publications
- Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
- Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
- Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
- 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.
- Senol D, Erdem C, Canbolat M, Toy S, Karatas T, Baykara RA, Ozbag D, Akyurek G. Comparison of the effects of conventional physiotherapy and proprioception exercises on pain and ankle proprioception in patients with lumbar radiculopathy. J Back Musculoskelet Rehabil. 2022;35(2):421-428. doi: 10.3233/BMR-200361.
- Kahlaee AH, Ghamkhar L, Arab AM. The Association Between Neck Pain and Pulmonary Function: A Systematic Review. Am J Phys Med Rehabil. 2017 Mar;96(3):203-210. doi: 10.1097/PHM.0000000000000608.
- Luoto S, Taimela S, Hurri H, Aalto H, Pyykko I, Alaranta H. Psychomotor speed and postural control in chronic low back pain patients A controlled follow-up study. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2621-7. doi: 10.1097/00007632-199611150-00012.
- Newcomer KL, Jacobson TD, Gabriel DA, Larson DR, Brey RH, An KN. Muscle activation patterns in subjects with and without low back pain. Arch Phys Med Rehabil. 2002 Jun;83(6):816-21. doi: 10.1053/apmr.2002.32826.
- Barden JM, Balyk R, Raso VJ, Moreau M, Bagnall K. Dynamic upper limb proprioception in multidirectional shoulder instability. Clin Orthop Relat Res. 2004 Mar;(420):181-9. doi: 10.1097/00003086-200403000-00025.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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/RCR&AHS/23/0212
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.
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