RCT of Multimodal Physiotherapy for Acute / Sub-acute Cervical Radiculopathy

NCT02449200 | Unknown

• 1 other identifier: GR 14-0917
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a research gap exists for optimal management in the first 12 weeks and short-term natural history of the condition is unclear, although thought to be favourable within the first 4 weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb unloading tape compared to advice to stay active, on disability, pain and other biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in self-reported disability and pain, compared to advice to stay active, in patients with acute / sub-acute cervical radiculopathy. A secondary study objective is to identify whether variables from the baseline examination, group allocation and aetiology confirmed by MRI can predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation, allocation concealment, blinded assessment and intention to treat analysis will be employed. Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability and their rating of recovery will also be recorded by telephone interview at 6 months. An internal pilot feasibility study will be undertaken in advance of the main study to test recruitment and retention strategies. Statistical analysis of differences between groups will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used to explore predictors of outcome.

Conditions

Cervical Radiculopathy

Keywords

cervical radiculopathy; exercise; manual therapy; tape

Outcome Measures

Primary Outcomes (2)

• Change from baseline in neck and arm pain (Numerical Pain Rating Scale)

  Neck and arm pain levels measured with the Numerical Pain Rating Scale for current, best and worst pain levels over last 24 hours (Jensen et al 1994)

  4 weeks

• Change from baseline in Neck Disability Index

  Disability resulting from the cervical radiculopathy measured with the Neck Disability Index (Vernon and Mior 1991)

  4 weeks

Secondary Outcomes (9)

• Cervical range of motion (ROM) measured with a CROM 3 device

  Baseline, 4 weeks and 12 weeks

• SF-12 version 2 Health Survey

  Baseline, 4 weeks and 12 weeks

• Pressure Pain Thresholds measured with a SenseBox pressure algometer

  Baseline, 4 weeks and 12 weeks

• Hospital Anxiety Depression Scale

  Baseline, 4 weeks and 12 weeks

• Upper Limb Neurodynamic test 1

  Baseline, 4 weeks and 12 weeks

Study Arms (2)

Multimodal physiotherapy group

EXPERIMENTAL

4 week multimodal physiotherapy treatment programme provided by an experienced musculoskeletal physiotherapist

Other: Multimodal physiotherapy

Advice to stay active group

NO INTERVENTION

Advice to stay active and continue use of prescribed medication as appropriate, via weekly phone calls from a physiotherapist over a 4 week period.

Interventions

Multimodal physiotherapy OTHER

Manual therapy, exercise and neural unloading tape provided twice weekly over 4 weeks by an experienced musculoskeletal physiotherapist

Multimodal physiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for CR diagnosis on a clinical prediction rule (CPR) by demonstrating positive responses to at least 3 of the following 4 clinical tests: Spurling's Test, Upper Limb Neural Tissue Provocation Test 1 (ULNT 1), Cervical Distraction Test, and less than 60° of cervical rotation on the symptomatic side (Wainner et al., 2003).
• Complaints of neck / periscapular pain, in addition to radicular pain, paraesthesia or numbness in the upper limb; aggravated by neck posture or movement (Thoomes et al., 2012).
• Symptom duration must be greater than 2 weeks and less than 3 months.
• Mean of Numerical Pain Rating Scale (NPRS) scores for both neck and arm pain must be ≥ 3/10.
• Fluent in spoken and written English.
• Willing to give informed consent.

You may not qualify if:

• Previous physiotherapy / manual treatment to cervical spine within past 6 months.
• Previous epidural injection since the onset of current symptoms.
• Prior surgery to the cervicothoracic spine or currently symptomatic upper limb.
• Current symptoms \& signs of bilateral radiculopathy.
• Myotomal paresis less than 4 / 5 on Medical Research Council Scale in affected upper limb.
• Signs and symptoms suggestive of Cervical Spondylotic Myelopathy (CSM): bilateral paraesthesia, hyperreflexia, positive Babinski reflex and spasticity.
• Diagnosis of any generalised neurological disorder e.g. multiple sclerosis.
• Concurrent peripheral neuropathy affecting either upper limb e.g. carpal tunnel syndrome, thoracic outlet syndrome.
• Medical red flags suggestive of serious pathology such as neoplastic conditions, upper cervical ligamentous instability, vertebral artery insufficiency and inflammatory or systemic disease (Childs et al., 2004).
• Diagnosis of fibromyalgia.
• Psychiatric diagnosis in past 6 months.
• Ongoing litigation relating to cervical symptoms.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Beaumont Hospital: collaborator
• EuroSpine - the Spine Society of Europe: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, 9, Ireland

RECRUITING

Related Publications (14)

• Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.

  PMID: 21168100 BACKGROUND

• Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.

  PMID: 22851876 BACKGROUND

• Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.

  PMID: 18758050 BACKGROUND

• Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.

  PMID: 18164333 BACKGROUND

• Cleland JA, Fritz JM, Whitman JM, Palmer JA. The reliability and construct validity of the Neck Disability Index and patient specific functional scale in patients with cervical radiculopathy. Spine (Phila Pa 1976). 2006 Mar 1;31(5):598-602. doi: 10.1097/01.brs.0000201241.90914.22.

  PMID: 16508559 BACKGROUND

• Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.

  PMID: 25629215 BACKGROUND

• Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: executive summary. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S5-7. doi: 10.1097/BRS.0b013e3181643f40. No abstract available.

  PMID: 18204400 BACKGROUND

• Jull, G., Sterling, M., Falla, D., Treleaven, J. & O'Leary, S. 2008. Whiplash, Headache and Neck Pain. Research-based directions for physical therapists., Churchill Livingstone.

  BACKGROUND

• Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy JS. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects. J Orthop Sports Phys Ther. 2015 Jan;45(1):4-17. doi: 10.2519/jospt.2015.5211.

  PMID: 25420010 BACKGROUND

• Nee RJ, Vicenzino B, Jull GA, Cleland JA, Coppieters MW. Neural tissue management provides immediate clinically relevant benefits without harmful effects for patients with nerve-related neck and arm pain: a randomised trial. J Physiother. 2012;58(1):23-31. doi: 10.1016/S1836-9553(12)70069-3.

  PMID: 22341379 BACKGROUND

• Rubinstein SM, Pool JJ, van Tulder MW, Riphagen II, de Vet HC. A systematic review of the diagnostic accuracy of provocative tests of the neck for diagnosing cervical radiculopathy. Eur Spine J. 2007 Mar;16(3):307-19. doi: 10.1007/s00586-006-0225-6. Epub 2006 Sep 30.

  PMID: 17013656 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Vicenzino B, Neal R, Collins D, Wright A. The displacement, velocity and frequency profile of the frontal plane motion produced by the cervical lateral glide treatment technique. Clin Biomech (Bristol). 1999 Oct;14(8):515-21. doi: 10.1016/s0268-0033(99)00011-x.

  PMID: 10521635 BACKGROUND

• Keating L, Treanor C, Sugrue J, Meldrum D, Bolger C, Doody C. A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy - the PACeR trial protocol. BMC Musculoskelet Disord. 2019 Jun 1;20(1):265. doi: 10.1186/s12891-019-2639-4.

  PMID: 31153362 DERIVED

Related Links

• PACeR trial website

MeSH Terms

Conditions

Radiculopathy; Motor Activity

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Louise Keating, MPhtySt

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Keating, MPhtySt

CONTACT

353 1 4022259; lkeating@rcsi.ie

Dara Meldrum, PhD

CONTACT

353 1 4022368; meldrumd@tcd.ie

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: May 5, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2015
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 28, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)