Clinical trial NCT04495465: Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain
Official title: Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Musculoskeletal Manipulations
Extracorporeal Shockwave Therapy
Keywords: Neck Pain
Musculoskeletal Manipulations
Extracorporeal Shockwave Therapy
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: experimental group and placebo group, receiving the intervention at the same time
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neck pain intensity
timeFrame: baseline
measure: Neck pain intensity
timeFrame: at one month
measure: Neck pain intensity
timeFrame: at two months
measure: Neck function
timeFrame: baseline
measure: Neck function
timeFrame: at one month
measure: Neck function
timeFrame: at two months
Secondary outcomes:
measure: temporomandibular pain intensity
timeFrame: baseline
measure: temporomandibular pain intensity
timeFrame: at one month
measure: temporomandibular pain intensity
timeFrame: at two months
measure: Temporomandibular joint function
timeFrame: baseline
measure: Temporomandibular joint function
timeFrame: at one month
measure: Temporomandibular joint function
timeFrame: at two months
measure: Health Related Quality of life
timeFrame: baseline
measure: Health Related Quality of life
timeFrame: at one month
measure: Health Related Quality of life
timeFrame: at two months
measure: Headache impact in quality of life.
timeFrame: baseline
measure: Headache impact in quality of life
timeFrame: at one month
measure: Headache impact in quality of life
timeFrame: at two months
measure: Dizziness
timeFrame: baseline
measure: Dizziness
timeFrame: at one month
measure: Dizziness
timeFrame: at two months
Other outcomes:
measure: weight
timeFrame: baseline
measure: height
timeFrame: baseline
measure: body mass index
timeFrame: baseline
Locations:
city: Dos Hermanas
country: Spain
facility: Clinica Fisiomedic
state: Sevilla
Study officials:
affiliation: University of Jaén
name: Rafael Lomas-Vega, PhD
role: PRINCIPAL_INVESTIGATOR
References: