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

NCT ID: NCT02033460

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Neck Pains; Posterior Cervical Pains; Posterior Neck Pain; Cervicalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Manual therapy, education and Exercise

The protocol for this group is identical to the previous group with the sole difference that is added an exercise protocol :

In the fifth session we explained the patients to perform :

• Five sets of isometric contraction of the deep neck flexors for 8-10 seconds.
• Five sets of isometric contraction of the neck extensors for 6-8 seconds
• Neural self-mobilization and stretching held for 10 - 12 seconds for the levator scapulae and the trapezius muscle.

In the sixth session the patient repeat all the exercises from the previous session and also with the help of a theraband made :

• Isotonic contraction of the head, performing 3-4 sets of 8-10 repetitions.

Group Type: EXPERIMENTAL

Manual Therapy and Education

Intervention Type: OTHER

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

Intervention Type: OTHER

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 and Education

The protocol used for therapeutic education consisted of two approaches:

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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Manual Therapy

Manual therapy will consist on Traction oscillatory, 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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy and Education

Intervention Type: OTHER

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, Education and Exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Autonoma de Madrid

OTHER

Sponsor Role: collaborator

Josue Fernandez Carnero

OTHER

Sponsor Role: lead

Responsible Party

Josue Fernandez Carnero

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Josue Fernandez-Carnero, PhD

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

References

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.

Reference Type: DERIVED

PMID: 25888653 (View on PubMed)

Other Identifiers

PI-551

Identifier Type: -

Identifier Source: org_study_id