NCT05021510

Brief Summary

Neck pain is a frequently reported complaint of the musculoskeletal system which generally has a huge impact on health care expenditure; ascribed to visits to health care providers, disability, and sick leaves. A variety of manual therapy techniques including Cervical traction (CT) and neural mobilization techniques (NMTs) have been prescribed in the management of CR because of their immediate analgesic effect. Both techniques have been proposed to reduce pain and functional limitations in CR. Traction increases the separation of the vertebral bodies which eventually reduces the central pressure in the disk space and encourages the disk nucleus to get back to a central position. The current literature lends assistance to the utilization of the traction in addition to other physical therapy procedures for pain reduction, with less significant impact on function and disability. Further studies should investigate to explore the most effective traction method and dosage, the subgroups of patients with CR, or the pain stage (acute, subacute, or chronic) most benefited by this intervention and the physical therapy procedures that yield the most effective outcomes when combined with traction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 15, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2021

Last Update Submit

February 23, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    NPRS for pain is a unidimensional measure of pain intensity. Similar to visual analogue scale (VAS), the NPRS is anchored by describing pain severity extremes. The NPRS can be administered verbally or graphically for self-completion.

    week 4

  • Neck Disability Index (NDI) for function

    NDI used to measure cervical pain and functional disability. The NDI was created using a questionnaire with 10 questions based on the Oswestry Index, which evaluates restrictions to ordinary life in relation to lumbar pain. The subjects selected a score of one to six (0 to 5) in 10 items: reading, headache, concentration, work, driving, sleeping, leisure life, pain intensity, ordinary life, and raising an object. The higher the sum of each item's score, the more severe the functional disability related to cervical abnormality. Zero to four points, five to 14 points, 15 to 24 points, 25 to 34 points, and 35 points or higher signify no disability, weak disability, moderate disability, severe disability, and complete disability, respectively

    week 4

  • Short Form Quality of Life 12: (physical, mental)

    The developers of short form (SF) 36 have consequently, suggested that a 12 item sub-set of the items may accurately reproduce the two summary component scores which can be derived from the SF 36 \[the physical component score (PCS) and the mental component score (MCS)\]. The scores were put in the free online orthopedic calculator "ortho tool kit" and two summary scores have been generated: Physical component score and mental component score.

    week 4

Study Arms (2)

Simultaneous Cervical Traction & Neural Mobilization

EXPERIMENTAL

Traction is a maneuver of distracting force to the cervical spine to cervical segments/grants decompression of nerve roots. For traction, 10% of the total body weight would be taken. Previous researches that investigated cervical traction found adequate effectiveness on pain reduction in neck and arm as well as improvement in nerve function parameters, and enhancement in neck mobility. The patient would be placed in a supine lying position with the cervical spine placed at 15º of flexion. The head strap will be fitted under the patient's occiput and chin. A safety switch will be given to the patient and ask him to press it if he would feel any kind of discomfort.

Other: Simultaneous Cervical Traction & Neural Mobilization

consecutive Cervical Traction & Neural Mobilization

ACTIVE COMPARATOR

the same description is for active comparator except for treatment mode to consecutive.

Other: consecutive Cervical Traction & Neural Mobilization

Interventions

Simultaneously Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks

Simultaneous Cervical Traction & Neural Mobilization

consecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks

consecutive Cervical Traction & Neural Mobilization

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with Chronic Cervical Radiculopathy for 6 months will be included.
  • Participants with Positive Spurling and Upper Limb Neural Tension Tests (ULNTTs) will be included.
  • Participants of age 20 to 60 will be included

You may not qualify if:

  • The participants with cervical myelopathy and other pathologies will not be included.
  • The participants with Vertigo/dizziness will not be included.
  • The participants with bilateral symptoms will not be included.
  • The participants with other musculoskeletal conditions in the affected limb will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Physiotherapy Clinic

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (7)

  • Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

    PMID: 25659245BACKGROUND
  • Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887.

    PMID: 30664500BACKGROUND
  • Savva C, Korakakis V, Efstathiou M, Karagiannis C. Cervical traction combined with neural mobilization for patients with cervical radiculopathy: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:279-289. doi: 10.1016/j.jbmt.2020.08.019. Epub 2020 Sep 2.

    PMID: 33992259BACKGROUND
  • Tarazona D, Boody B, Hilibrand AS, Stull J, Bell K, Fang T, Goyal D, Galetta M, Kaye D, Kepler CK, Kurd MF, Woods BI, Radcliff KE, Rihn JA, Anderson DG, Vaccaro AR, Schroeder GD. Longer Preoperative Duration of Symptoms Negatively Affects Health-related Quality of Life After Surgery for Cervical Radiculopathy. Spine (Phila Pa 1976). 2019 May 15;44(10):685-690. doi: 10.1097/BRS.0000000000002924.

    PMID: 30395087BACKGROUND
  • Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.

    PMID: 25892373BACKGROUND
  • Romeo A, Vanti C, Boldrini V, Ruggeri M, Guccione AA, Pillastrini P, Bertozzi L. Cervical Radiculopathy: Effectiveness of Adding Traction to Physical Therapy-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Apr 1;98(4):231-242. doi: 10.1093/physth/pzy001.

    PMID: 29315428BACKGROUND
  • Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.

    PMID: 23024624BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Arshad Malik, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 25, 2021

Study Start

August 15, 2021

Primary Completion

August 20, 2022

Study Completion

August 20, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations