Adding Two Different Types of Manual Techniques to an Exercise Program for the Management of Chronic Neck Pain

NCT ID: NCT04327739

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-06-30

Brief Summary

Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.

The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.

An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.

Detailed Description

Background Neck pain is one of the most common and costly musculoskeletal disorders in western societies with a high rate of recurrence and chronicity. In chronic neck pain, the persistence of symptoms is highly associated with changes in the biomechanics of the neck region that are related to the muscular imbalance between the neck muscles and specifically between the deep and superficial neck flexors. Manual techniques are special techniques applied by hand from the therapist that focus on reducing symptoms and improving disability. Both spinal manipulation and soft tissue mobilization techniques have a positive effect in individuals with chronic neck pain, especially when they are combined with the appropriate therapeutic exercise programme. However, it has not been determined which of the above-mentioned combinations is more effective in patients with chronic neck pain.

Aim The aim of this study is to compare the efficacy of two different kinds of manual technique, when they combine with the same therapeutic exercise program in the management of patients with chronic neck pain.

Method An assessor-blind randomized control trial with a duration of ten weeks and a 6-month follow up will be performed in 80 women with chronic neck pain. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). The first three groups will follow the same exercise program. Only exercise will be applied to the first group. The second group will apply a combination of soft tissue mobilization techniques and exercise. The third group will follow a combination of spinal manipulation and exercise, while the fourth group will not receive any treatment. The neck pain will be evaluated with the visual analogue scale, the disability related to neck pain with the neck disability index, the pressure pain threshold of the neck muscles with pressure algometry, the active range of motion with a bubble inclinometer, the maximum isometric strength of the neck muscles with a hand dynamometer, the muscular fatigue of the flexors of the neck with the craniocervical flexion test and the quality of life with the sf-36 questionnaire before, during and after the intervention, while follow-ups will take place six months later.

Conditions

Neck Pain

Study Design

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

Study Groups

Intervention 1 Exercise

Participants allocated to this group received a 10 weeks exercise programme for neck and upper limbs muscles

Group Type: EXPERIMENTAL

Intervention 1 Exercise

Intervention Type: OTHER

• Exercise programme Endurance and Resistant training exercise program (Duration: 45 minutes) • Muscle retraining of longus colli and endurance training of the deep cervical flexors. • Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM). • Active ROM exercises for the neck muscles • Upper limbs exercises with resistant bands • Stretching exercises for the neck and upper limbs muscles

Intervention 2 Exercise and INIT

Participants allocated to this group received the same exercise programme as group 1 in combination with the integrated neuromuscular inhibition technique (INIT)

Group Type: EXPERIMENTAL

Intervention 2 Exercise and INIT

Intervention Type: OTHER

• Exercise programme same as Intervention Group 1 and
• Integrated Neuromuscular Inhibition Technique application. Integrated Neuromuscular Inhibition Technique application. (Duration: 15min) The protocol was applied to the following muscles: • Upper border of the trapezius muscle • sternocleidomastoid • levator scapulae muscle • splenius capitis muscle Integrated Neuromuscular Inhibition Technique includes the combination of the following technique: • Ischemic compression • Muscle energy technique • Straincounterstrain technique

Intervention 3 Exercise and SMT

Participants allocated to this group received the same exercise programme as group 1 in combination with cervical manipulation

Group Type: EXPERIMENTAL

Intervention 3 Exercise and SMT

Intervention Type: OTHER

• Exercise programme same as Intervention Group 1 and
• Manipulation Care. Participants allocated to this group received Spinal Manipulation Therapy after the therapeutic exercise programme. Treatment was delivered by 1 chiropractor with a minimum 5-year experience of clinical practice. Pain provocation and static/motion palpation findings were used to determine areas of treatment in the cervical spine. The Manipulation Therapy technique included joint motion using a diversified thrust technique, and mobilization, a low-velocity type of joint oscillation. The type and the force of the applied spinal manipulation were individualized according to the age and physical condition of each participant. Soft passive stretching, light massage and hot packs were applied to the cervical and upper thoracic area before manipulation in order to prepare each participant.

Control

Participants allocated to this group received general consulting instructions and a home based general exercise sheet

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Participants allocated to this group received general consulting istructions and a home based general exercise sheet

Interventions

Intervention 1 Exercise

• Exercise programme Endurance and Resistant training exercise program (Duration: 45 minutes) • Muscle retraining of longus colli and endurance training of the deep cervical flexors. • Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM). • Active ROM exercises for the neck muscles • Upper limbs exercises with resistant bands • Stretching exercises for the neck and upper limbs muscles

Intervention Type: OTHER

Intervention 2 Exercise and INIT

• Exercise programme same as Intervention Group 1 and
• Integrated Neuromuscular Inhibition Technique application. Integrated Neuromuscular Inhibition Technique application. (Duration: 15min) The protocol was applied to the following muscles: • Upper border of the trapezius muscle • sternocleidomastoid • levator scapulae muscle • splenius capitis muscle Integrated Neuromuscular Inhibition Technique includes the combination of the following technique: • Ischemic compression • Muscle energy technique • Straincounterstrain technique

Intervention Type: OTHER

Intervention 3 Exercise and SMT

• Exercise programme same as Intervention Group 1 and
• Manipulation Care. Participants allocated to this group received Spinal Manipulation Therapy after the therapeutic exercise programme. Treatment was delivered by 1 chiropractor with a minimum 5-year experience of clinical practice. Pain provocation and static/motion palpation findings were used to determine areas of treatment in the cervical spine. The Manipulation Therapy technique included joint motion using a diversified thrust technique, and mobilization, a low-velocity type of joint oscillation. The type and the force of the applied spinal manipulation were individualized according to the age and physical condition of each participant. Soft passive stretching, light massage and hot packs were applied to the cervical and upper thoracic area before manipulation in order to prepare each participant.

Intervention Type: OTHER

Control

Participants allocated to this group received general consulting istructions and a home based general exercise sheet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women with chronic neck pain with a duration of symptoms for at least three months
• Existence of at least one active or latent trigger point in any of the muscles: levator scapulae, upper trapezoid, and splenius capitis
• Patients whose neck pain has emerged as a result of a specific pathology, confirmed by radio-diagnostic tests (X-ray or MRI)
• Patients with a medical referral for physical therapy with the etiology of neck pain

Exclusion Criteria

• Included the acute stage of symptoms confirmed by visual analog scale (VAS; score >70 mm)
• Participation in any kind of treatment during the past 3 months (e.g., physiotherapy, massage, local injections of anesthetic blocks)
• Participation in an exercise program concerning the neck muscles during the past 6 months
• Background of neck trauma and/or surgery in the neck region
• Inflammatory muscle diseases, joint infections, and malignancy.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

LYTRAS DIMITRIOS

Dimitrios Lytras PT, Phd, Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evaggelos Sykaras, PT, PhD

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

Aristotle University of Thessaloniki

Thessaloniki, Central Makedonia, Greece

Department of Physical Education and Sports Sciences

Thessaloniki, Thermi, Greece

Countries

Greece

Other Identifiers

256445/2019

Identifier Type: -

Identifier Source: org_study_id