Effectiveness of Manual Therapy in Patients With Neck Pain.

NCT00713843 | Completed DMC

• 1 other identifier: NL21128.091
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Background of the study: Manual Therapy applied to patients with non-specific neck pain has been investigated several times, both internationally and nationally. In the Netherlands different types of manual therapy treatment exist. Manual Therapy, as practiced under the Utrecht School, has not been subject of a randomized controlled trial. There is a need to evaluate the effectiveness of this type of manual therapy. Objective of the study: This trial will investigate the effectiveness of Manual Therapy in the short and long-term up to 52 weeks in patient with (sub) acute (minimal two weeks) and chronic (maximum 52 weeks) since last episode of neck pain. Functional state, pain and global perceived effect are the outcome variables. Study design: The study is a single blind randomized controlled trial. Study population: Men and women aged 18 to 70 years old with neck pain for at least two weeks. Intervention: The experimental group will be treated with manual therapy for a period of six weeks. The control group will be treated with physical therapy (usual care) also for a period of six weeks. Primary study parameters / outcome of the study: Global Perceived Effect (GPE) and the Neck disability index (NDI-DV ) will be applied. Secondary study parameters / outcome of the study: Visual Analogue Scale (VAS) for pain and SF36 (Quality of life). The Multidimensional Health Locus of Control(MHLC ), Credibility/Expectancy Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ-DLV) will also be measured.

Conditions

Neck Pain

Keywords

Neck Pain; Manuel Therapy Utrecht; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Global Perceived Effect (GPE), Neck disability index (NDI-DV )

  0-3-7-13-26-52 weeks

Secondary Outcomes (1)

• Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS)for pain and SF36 (Quality of life). Multidimensional Health Locus of Control (MHLC), credibility/ expectancy, Fear Avoidance Beliefs Questionaire (FABQ-DLV)

  0-3-7-13-26-52 weeks

Study Arms (2)

1 Manual Therapy Utrecht

EXPERIMENTAL

Manual Therapy Utrecht (MTU) During the first consultation the manual therapist enquires about the complaints of the patient. The manual therapist conducts a number of measurements according to protocol. During treatment preferred movements are executed by the manual therapist in the patient's joints. The treatment techniques used by the manual therapist are very gentle mobilizations, without high velocity thrust techniques and are in general painless. In Manual Therapy Utrecht (MTU) it is common to give advices and recommend exercises. A treatment session lasts between 30 and 60 minutes (repeated after one or two weeks). The maximum number of sessions is six. The manual therapist has a minimum of five years of working experience.

Other: Manual Therapy Utrecht

2 Physical Therapy - Exercise Therapy

ACTIVE COMPARATOR

The physical therapist conducts a complaint related function examination. Treatment consist of active exercises, manual traction or stretching and massage. The aims of active exercises are improvement of strength, mobility and movement coordination. Specific mobilization techniques are not a part of physiotherapeutic treatment. Treatment sessions take place no more than twice a week with a maximum of nine sessions (approximately 30 minutes) with a minimum of twenty minutes on active exercise therapy combined with instruction. To prevent overlap with MTU (experimental arm), physical therapists are selected who are not (also) trained as manual therapists or have started this education. The physical therapist has at least five years of working experience.

Other: Physical Therapy

Interventions

Manual Therapy Utrecht OTHER

Manual Therapy (6 weeks).

Also known as: joint mobilisation and manipulation, exercise therapy with instruction

1 Manual Therapy Utrecht

Physical Therapy OTHER

Physical Therapy (six weeks).

Also known as: exercise therapy with instruction, massagetherapy

2 Physical Therapy - Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least two weeks of neck pain
• Last episode starts at a maximum of one year ago
• Age between 18 and 70 years
• Patient is willing to undergo the treatment
• Neck pain is mechanical and can be provocated by movements or postures of the neck
• Neck pain is the main problem to treat
• Neck pain may also give pain in the upper arm or cervicogenic headaches

You may not qualify if:

• Appearance of "red flags"
• Cervical surgery in the past
• Pregnancy
• Whiplash trauma
• Health conditions with may disturb the treatment or makes it impossible to undergo the treatment.
• Not enough understanding of the Dutch questionnaires
• Undergoing treatments like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture, other types of exercise therapy during the last three months

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

NECKproject.nl

Dordrecht, South Holland, 3300 VB, Netherlands

Location

Related Publications (4)

• Groeneweg R, Haanstra T, Bolman CAW, Oostendorp RAB, van Tulder MW, Ostelo RWJG. Treatment success in neck pain: The added predictive value of psychosocial variables in addition to clinical variables. Scand J Pain. 2017 Jan;14:44-52. doi: 10.1016/j.sjpain.2016.10.003. Epub 2016 Nov 2.

  PMID: 28850429 DERIVED

• Groeneweg R, van Assen L, Kropman H, Leopold H, Mulder J, Smits-Engelsman BCM, Ostelo RWJG, Oostendorp RAB, van Tulder MW. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial. Chiropr Man Therap. 2017 Apr 28;25:12. doi: 10.1186/s12998-017-0141-3. eCollection 2017.

  PMID: 28465824 DERIVED

• van Dongen JM, Groeneweg R, Rubinstein SM, Bosmans JE, Oostendorp RA, Ostelo RW, van Tulder MW. Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial. Eur Spine J. 2016 Jul;25(7):2087-96. doi: 10.1007/s00586-016-4526-0. Epub 2016 Mar 21.

  PMID: 27001136 DERIVED

• Groeneweg R, Kropman H, Leopold H, van Assen L, Mulder J, van Tulder MW, Oostendorp RA. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT). BMC Musculoskelet Disord. 2010 Jan 24;11:14. doi: 10.1186/1471-2474-11-14.

  PMID: 20096136 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise Therapy; Educational Status; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Socioeconomic Factors; Population Characteristics

Study Officials

• Rob Oostendorp, Prof. dr.

  UMC St Radboud, IQ healthcare, Nijmegen

  STUDY CHAIR

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: PRINCIPAL INVESTIGATOR
• PI Title: emeritus professor Allied Heath Sciences

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 14, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

NL (1)