Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain

NCT ID: NCT04495465

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-02-26

Brief Summary

The aim of this study is to assess the effects of radial shock wave therapy in neck pain. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. Neck pain, neck function, temporomandibular pain, temporomandibular function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.

Detailed Description

Neck pain is defined as discomfort or more intense forms of pain that are localized to the cervical region. The multifactorial etiology of neck pain includes trauma, ergonomic factors such as inappropriate postures, repetitive movements, strong physical activity, individual factors such as age, BMI, genetic factors, behavioral factors, and psychosocial factors.

The prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a short time and the other half will suffer pain for a longer time. There is a higher prevalence in widows and separated, people with few economic resources, jobs that involve physical effort, low educational level, anxiety and depression. Furthermore, there is a high relationship between cervical pain and temporomandibular disorders.

From this study, the investigators are going to carry out a non-invasive, analgesic, antiinflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (rESWT), and manual therapy (TM). Among the effects produced by shock waves the investigators find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle relaxation.

The main objective of the study is to evaluate the capacity of the shock waves to improve the alterations due to neck pain. To meet the above objective, a single-blind randomized clinical trial study has been designed. The selected subjects will be of legal age diagnosed with neck pain and those subjects that due to their own characteristics are not able to carry out the study will be excluded. Subjects will receive a weekly physical therapy session for four weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of subjects who will receive manual therapy treatment and shock waves and T2 placebo group in which the subjects will receive manual therapy and placebo shock waves.

Conditions

Neck Pain; Musculoskeletal Manipulations; Extracorporeal Shockwave Therapy

Study Design

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

Study Groups

Experimental group: manual therapy + shock waves

Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of extracorporeal radial shock waves therapy on painful points of neck muscles at 2 bars and 10 Hetzs.

Group Type: EXPERIMENTAL

Radial Shock Wave Therapy

Intervention Type: OTHER

2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs

Manual Therapy

Intervention Type: OTHER

25 minute massage to neck muscles

Control group: manual therapy + placebo shock waves

Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.

Group Type: PLACEBO_COMPARATOR

Manual Therapy

Intervention Type: OTHER

25 minute massage to neck muscles

placebo shock waves

Intervention Type: OTHER

3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.

Interventions

Radial Shock Wave Therapy

2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs

Intervention Type: OTHER

Manual Therapy

25 minute massage to neck muscles

Intervention Type: OTHER

placebo shock waves

3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.

Intervention Type: OTHER

Other Intervention Names

Extracorporeal Shockwave Therapy; Musculoskeletal Manipulations

Eligibility Criteria

Inclusion Criteria

• Subjects diagnosed of neck pain.

Exclusion Criteria

• Subjects who due to their own characteristics are not able to carry out the study tests

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

NOELIA ZAGALAZ ANULA

Health Sciences Department Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael Lomas-Vega, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jaén

Locations

Clinica Fisiomedic

Dos Hermanas, Sevilla, Spain

Countries

Spain

Other Identifiers

UJAShockWavesNeck2020

Identifier Type: -

Identifier Source: org_study_id