NCT05922228

Brief Summary

the goal of this clinical trial is to determine the effects of neural flossing with and without proprioceptive neuromuscular facilitation on pain, range of motion and disability in patients with lumbar radiculopathy. the main question it aim to answer is :- Does proprioceptive neuromuscular facilitation added benefit when combined with neural flossing to pain, range of motion and disability in lumbar radiculopathy patients? Research will compare the neural flossing group with the group receiving neural flossing with proprioceptive neuromuscular facilitation to see if there is any difference in the outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 6, 2023

Last Update Submit

June 26, 2023

Conditions

Keywords

DisabilityLumbarPNFNeural flossingpain

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    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

    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)

    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

Study Arms (2)

Neural flossing with proprioceptive neuromuscular facilitation

EXPERIMENTAL

nerve flossing technique protocol along with contract relax technique of proprioceptive neuromuscular facilitation is used

Other: neural flossing with proprioceptive neuromuscular facilitation

Neural flossing without proprioceptive neuromuscular facilitation

ACTIVE COMPARATOR

only nerve flossing technique protocol is used

Other: Neural flossing without proprioceptive neuromuscular facilitation

Interventions

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

Neural flossing with proprioceptive neuromuscular facilitation

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

Neural flossing without proprioceptive neuromuscular facilitation

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive impairment.
  • Using pain modulating medicines.
  • Patients with comorbidities.
  • Pain radiating above to knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz Bhatti Shaheed Teaching Hospital

Dhok Gujra, Punjab Province, 50700, Pakistan

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22543563BACKGROUND
  • 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.

    PMID: 21665125BACKGROUND
  • 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: 32931763BACKGROUND
  • 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.

    PMID: 34308899BACKGROUND
  • 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.

    PMID: 30074971BACKGROUND
  • 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.

    PMID: 27610549BACKGROUND
  • 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.

    PMID: 8961450BACKGROUND
  • 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.

    PMID: 12048661BACKGROUND
  • 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.

    PMID: 15057095BACKGROUND
  • 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.

    PMID: 30582917BACKGROUND

MeSH Terms

Conditions

RadiculopathyPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wajiha Shahid, phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

June 6, 2023

First Posted

June 28, 2023

Study Start

November 11, 2022

Primary Completion

August 15, 2023

Study Completion

October 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations