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

A

Aristotle University Of Thessaloniki

Status

Completed

Conditions

Neck Pain

Treatments

Other: Control
Other: Intervention 1 Exercise
Other: Intervention 3 Exercise and SMT
Other: Intervention 2 Exercise and INIT

Study type

Interventional

Funder types

Other

Identifiers

NCT04327739
256445/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 4 patient groups, including a placebo group

Intervention 1 Exercise
Experimental group
Description:
Participants allocated to this group received a 10 weeks exercise programme for neck and upper limbs muscles
Treatment:
Other: Intervention 1 Exercise
Intervention 2 Exercise and INIT
Experimental group
Description:
Participants allocated to this group received the same exercise programme as group 1 in combination with the integrated neuromuscular inhibition technique (INIT)
Treatment:
Other: Intervention 2 Exercise and INIT
Intervention 3 Exercise and SMT
Experimental group
Description:
Participants allocated to this group received the same exercise programme as group 1 in combination with cervical manipulation
Treatment:
Other: Intervention 3 Exercise and SMT
Control
Placebo Comparator group
Description:
Participants allocated to this group received general consulting instructions and a home based general exercise sheet
Treatment:
Other: Control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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