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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05021510
Other study ID # REC/01030 Sabah
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date August 20, 2022

Study information

Verified date February 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Researchers have started exploring that neural tissue mobilization along with conventional treatment is more effective in decreasing pain and improving cervical range of motion and mental component of quality of life in unilateral cervical radiculopathy (CR) patients than intermittent cervical traction and conventional treatment. Future randomized controlled trials are warranted with the purpose to compare the long-term effectiveness of cervical traction with neural mobilization in CR, as well as the effect of these two techniques in comparison with other interventions. Some literature recommended the simultaneous application of mechanical cervical traction along with neural mobilization in the treatment of Unilateral Cervical Radiculopathy. There are numerous studies in which both groups received Cervical traction (CT) and neural mobilization (NM) was added in only one group along with cervical traction or studies in which both groups received NM and CT was administered in only one group as well, there are also some studies in which one group received only CT and other group received only NM but there isn't any study yet in which we can compare the effect of simultaneous administration of CT and NM and consecutive administration of CT and NM. Pain and functional limitation in cervical radiculopathy can be treated with mechanical cervical traction and neural mobilization. The purpose of the study is to determine that is simultaneous administration of cervical traction and neural mobilization is more effective than consecutive administration in the management of cervical radiculopathy. The findings of the study will provide an insight into the low-cost evidence-based conservative management of cervical radiculopathy.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 20, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Simultaneous Cervical Traction & Neural Mobilization
Simultaneously 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
consecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks

Locations

Country Name City State
Pakistan The Physiotherapy Clinic Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Phys Ther. 2018 Aug 1;98(8):727. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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