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

NCT04495465 | Completed

• 1 other identifier: UJAShockWavesNeck2020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Musculoskeletal Manipulations; Extracorporeal Shockwave Therapy

Keywords

Neck Pain; Musculoskeletal Manipulations; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (6)

• Neck pain intensity

  Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.

  baseline

• Neck pain intensity

  Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.

  at one month

• Neck pain intensity

  Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.

  at two months

• Neck function

  Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50.

  baseline

• Neck function

  Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50

  at one month

• Neck function

  Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50

  at two months

Secondary Outcomes (15)

• temporomandibular pain intensity

  baseline

• temporomandibular pain intensity

  at one month

• temporomandibular pain intensity

  at two months

• Temporomandibular joint function

  baseline

• Temporomandibular joint function

  at one month

Other Outcomes (3)

• weight

  baseline

• height

  baseline

• body mass index

  baseline

Study Arms (2)

Experimental group: manual therapy + shock waves

EXPERIMENTAL

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.

Other: Radial Shock Wave Therapy; Other: Manual Therapy

Control group: manual therapy + placebo shock waves

PLACEBO COMPARATOR

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.

Other: Manual Therapy; Other: placebo shock waves

Interventions

Radial Shock Wave Therapy OTHER

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

Also known as: Extracorporeal Shockwave Therapy

Experimental group: manual therapy + shock waves

Manual Therapy OTHER

25 minute massage to neck muscles

Also known as: Musculoskeletal Manipulations

Control group: manual therapy + placebo shock waves; Experimental group: manual therapy + shock waves

placebo shock waves OTHER

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

Control group: manual therapy + placebo shock waves

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed of neck pain.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Clinica Fisiomedic

Dos Hermanas, Sevilla, 41701, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Extracorporeal Shockwave Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Complementary Therapies

Study Officials

• Rafael Lomas-Vega, PhD

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Department Professor

Model Details: Two groups: experimental group and placebo group, receiving the intervention at the same time

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 31, 2020
• Study Start: January 1, 2021
• Primary Completion: January 19, 2021
• Study Completion: February 26, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)