Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain

Cervicalgia Clinical Trial

Official title:

Manual Therapy vs Manual Therapy and Exercise vs Manual Therapy and Exercise and Education in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033460
• Other study ID #: PI-551
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 10, 2014
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicalgia
• Neck Pain
• Neck Pains
• Posterior Cervical Pains
• Posterior Neck Pain

Intervention

Other:
• Manual Therapy and Education
Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective will add to manual therapy treatment.
• Manual Therapy
Manual therapy will consist on Traction oscillatory, Maintained traction in the craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral C1- C2 ( 2 minutes) , C2 -C3, and C5 -C6 and High-velocity technique in dorsal region.
• Manual therapy, Education and Exercise
Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective and Craniocervical exercise will add to this arm.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Josue Fernandez Carnero	Universidad Autonoma de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	This scale comprises of a 100-mm horizontal line with pain descriptors marked "no pain" at left side and "the worst pain imagine" at the right side, and is used to measure the pain intensity. It was recorded at the beginning of the physical assessment and the patient was asked what their pain intensity was at the time by marking the VAS with a perpendicular line. This is a valid method to measure the pain level37 and psychometric properties of the VAS have been reported widely. The minimal important difference of the VAS is based on detecting an 8.6 mm (based in previous study for a score < 40mm with a pain onset more than 12 weeks) of difference immediately after treatment.	pre-treatment, 4, 8, 16 weeks	No
Primary	Pressure Pain threshold	Pressure pain threshold (PPT) is defined as the amount of pressure where the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA), will be used. Pressure pain threshold was assessed over right side of masseter 1 and 2, the temporalis muscle 1 and 2, suboccipital muscle, spinous process of C2, vertebral joint process of C5 y C6, upper trapezius muscle (midway between C7 and acromion), epicondyle, scaphoid bone and tibialis anterior muscle (upper one-third of the muscle belly) by an assessor blinded to the subject's condition.	pre-treatment, 4, 8, 16 weeks	No
Primary	Cervical Range of Motion	Cervical spine mobility was measured with Cervical Range of Motion (CROM) device (Performance Attainment Associates, MN). The CROM is an instrument that assesses the active range of motion of the cervical segment. It´s a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. The patients were measured while sitting with the back against a chair. The goniometer placed over his head, is asked to perform analytical neck movements (flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation).	pre-treatment, 4, 8, 16 weeks	No
Primary	Neck disability index	It is a well-validated 10-item questionnaire. The Neck Disability Index (NDI) has sufficient support in the literature, to be the most commonly used to report neck pain. It was used a spanish validation of the index. Scores of <4 indicate no disability, 5-14 mild disability, 15-25 moderate disability, 25-34 severe disability and >35 complete disability	pre-treatment, 4, 8, 16 weeks	No
Secondary	Kinesiophobia	The Tampa Scale for Kinesiophobia, developed by Miller was used to assess fear of movement and injury. We used a 11-items version.	Pre-treatment, 4, 8, 16 weeks	No
Secondary	Catastrophizing	To evaluate the subject's propensity to catastrophize about pain we used the Spanish version of Pain Catastrophizing Scale (PCS). This scale is a 13-item questionnaire designed to measure the three components of catastrophizing: rumination, magnification and helplessness, resulting this evaluation in a unique score.	Pre-treatment, 4, 8, 16 weeks	No
Secondary	Fear Avoidance Belief Questionnaire (FABQ)	The FABQ assesses patient beliefs with regard to the effect of physical activity and work on their pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree).	Pre-treatment, 4, 8, 16 weeks	No