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

NCT02033460 | Completed

• 1 other identifier: PI-551
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Manual therapy; Exercise; Education

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• Kinesiophobia

  Pre-treatment, 4, 8, 16 weeks

• Catastrophizing

  Pre-treatment, 4, 8, 16 weeks

• Fear Avoidance Belief Questionnaire (FABQ)

  Pre-treatment, 4, 8, 16 weeks

Study Arms (3)

Manual therapy, education and Exercise

EXPERIMENTAL

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.

Other: Manual Therapy and Education; Other: Manual Therapy

Manual Therapy and Education

ACTIVE COMPARATOR

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.

Other: Manual Therapy; Other: Manual therapy, Education and Exercise

Manual Therapy

ACTIVE COMPARATOR

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.

Other: Manual Therapy and Education; Other: Manual therapy, Education and Exercise

Interventions

Manual Therapy and Education 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; Manual therapy, education and Exercise

Manual Therapy 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; Manual therapy, education and Exercise

Manual therapy, Education and Exercise 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 and Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josue Fernandez Carnero: lead
• Universidad Autonoma de Madrid: collaborator

Related Publications (1)

• 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.

  PMID: 25888653 DERIVED

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Musculoskeletal Manipulations; Educational Status; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Josue Fernandez-Carnero, PhD

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01