Clinical Trials Directory

Trials / Completed

CompletedNCT04327739

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

Effects of Adding Two Different Types of Manual Techniques to a Therapeutic Exercise Program for the Management of Chronic Neck Pain: A Randomized Controlled Trial of Comparative Effectiveness

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Aristotle University Of Thessaloniki · Academic / Other
Sex
Female
Age
30 Years – 60 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERIntervention 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
OTHERIntervention 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
OTHERIntervention 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.
OTHERControlParticipants allocated to this group received general consulting istructions and a home based general exercise sheet

Timeline

Start date
2020-06-30
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2020-03-31
Last updated
2021-07-22

Locations

2 sites across 1 country: Greece

Source: ClinicalTrials.gov record NCT04327739. Inclusion in this directory is not an endorsement.