Clinical trial NCT04327739: Adding Two Different Types of Manual Techniques to an Exercise Program for the Management of Chronic Neck Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Chronic Neck Pain
Exercise
Manual techniques
Spinal manipulation
Integrated neuromuscular inhibition technique
Rehabilitation
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in neck pain intensity with visual analogue scale (VAS)
timeFrame: pre-treatment, Week: 2, 4, 6,10, 34
measure: Changes in Pressure Pain threshold with pressure algometry
timeFrame: pre-treatment, Week: 2, 4, 6, 10, 34
measure: Changes in functional capacity with the Greek Version of Neck disability index questionnaire
timeFrame: pre-treatment, Week 6, 10, 34
measure: Changes in maximum isometric strength of neck muscles with Manual Muscular Testing
timeFrame: pre-treatment, Week: 2, 4, 6, 10, 34
measure: Changes in Cervical Range of Motion with bubble inclinometers
timeFrame: pre-treatment, Week: 2, 4, 6, 10, 34
measure: Changes in deep flexors muscle endurance with craniocervical flexion test
timeFrame: pre-treatment, Week: 2, 4, 6, 10, 34
measure: Changes in quality of life with the sort form of SF-36 Health Survey
timeFrame: pre-treatment, Week: 10, 34
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
state: Central Makedonia
city: Thessaloniki
country: Greece
facility: Department of Physical Education and Sports Sciences
state: Thermi
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Evaggelos Sykaras, PT, PhD
role: STUDY_DIRECTOR
References: