Clinical trial NCT05393323: Effects of Cervical Distraction Versus Cervical Traction Techniques on Upper Cervical Pain
Official title: Effects of Cervical Distraction Versus Cervical Traction Techniques on Pain, Range of Motion and Function in Patients With Upper Cervical Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Cervical pain
Traction
Distraction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive cervical distraction technique with conventional physical therapy while Group B will receive cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25

Detailed description: The term collectively used for musculoskeletal conditions originating from cervical area is known as neck pain. According to the Global burden of disease (2010) study, neck pain is the fourth agent which is the reason behind chronic disability. The incidence of cervical pain in the adult population aged 15 to 74 years is 5.92% to 38.7% and it is more prevalent in women than men. The best predictor of future neck pain is the presence of an episode of neck pain in the past. Cervical rotation deficits are noted mostly in upper cervical spine issues as in atlantoaxial joint pathology.

The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be a randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive the cervical distraction technique with conventional physical therapy while Group B will receive the cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25.

Eligibility criteria: Inclusion Criteria:

* Minimum 3 months chronicity of upper cervical pain
* Positive ﬂexion-rotation test (asymmetry of \>10◦ between sides or less than 32◦ in any direction)
* hypomobility in one or more segments of C0-1, C1-2, or C2-3

Exclusion Criteria:

* Congenital abnormalities (Cervical torticollis)
* Past surgical history of cervical spine
* Any history of neck trauma
* Already undergone physiotherapy treatment

Primary outcomes:
measure: NPRS
timeFrame: 4th week
measure: NDI
timeFrame: 4th Week
measure: Goniometric measurement
timeFrame: 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Mehmooda begum medical complex
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil-ur Rehman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaishy S, Kondal S. Effect of Vertical Cervical traction Combined with Conventional Neurodynamic Mobilization and SNAGs in an Individual with Neck Pain and Cervical Radiculopathy: A Case Report.
citation: Khan K, Yasmeen S, Ishaque F, Imdad F, Shaikh SA, Nawaz U, et al. A RANDOMIZED CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY OF MANUAL TRACTION ON PAIN AND RANGE OF MOTION IN CERVICAL RADICULOPATHY.
citation: Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
citation: Windsor RE, Malanga G, Benjamin M, Chawla J. Cervical spine anatomy. Medscape; 2017.
citation: Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
citation: Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
citation: Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
citation: Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
citation: Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.
citation: Afzal R, Ghous M, Shakil Ur Rehman S, Masood T. Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. J Pak Med Assoc. 2019 Sep;69(9):1237-1241.