Clinical trial NCT02033460: Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain
Official title: Manual Therapy vs Manual Therapy and Exercise vs Manual Therapy and Exercise and Education in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pains
Posterior Cervical Pains
Posterior Neck Pain
Cervicalgia
Keywords: Manual therapy
Exercise
Education
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Madrid
First posted: 2014-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to know which combination of treatments are the most effective in patients with non-specific neck pain. Study design: This is a single-blind randomized controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a period of 4 weeks (8 sessions total; 2 per week).

Detailed description: Nonspecific chronic neck pain has a high prevalence and is very common in clinical practice.

Manual therapy (MT) studies of techniques like mobilization, manipulation, and therapeutic exercise, has been demonstrated effectiveness for the treatment of pain and disability in the neck. These investigations have thought of this treatments as individual interventions. Thus, multimodal ways of treatment to improve patients with nonspecific chronic neck pain are necessary.

The aim of this study is to evaluate the effectiveness of a multimodal treatment protocol compared to a unimodal treatment protocol in the medium-term, on patients with chronic non-specific neck pain.

Subjects are randomly allocated into three groups: MT group; MT+Educational therapy (ET) group; and MT+ET+Exercise group. Each subject receive a 4 weeks period treatment (8 sessions). Outcome measures include physical, somatosensory, and psychosocial characteristics; which are measure at 0, 4, 8, 16 weeks by a blinded assessor.

Eligibility criteria: Inclusion Criteria:

* The subjects for the study were selected if they fulfilled the following inclusion criteria: Aged between 18 to 60 years old, head and/or neck pain for at least 12 weeks and having the willing to undergo the treatment.

Exclusion Criteria:

* if they had appearance of "red flags", rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.

Primary outcomes:
measure: visual analogue scale
timeFrame: pre-treatment, 4, 8, 16 weeks
measure: Pressure Pain threshold
timeFrame: pre-treatment, 4, 8, 16 weeks
measure: Cervical Range of Motion
timeFrame: pre-treatment, 4, 8, 16 weeks
measure: Neck disability index
timeFrame: pre-treatment, 4, 8, 16 weeks
Secondary outcomes:
measure: Kinesiophobia
timeFrame: Pre-treatment, 4, 8, 16 weeks
measure: Catastrophizing
timeFrame: Pre-treatment, 4, 8, 16 weeks
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Pre-treatment, 4, 8, 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernandez-Carnero, PhD
role: STUDY_DIRECTOR
References:
citation: Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.