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Clinical Trials/NCT06507761
NCT06507761
Recruiting
Not Applicable

Comparison of the Short-term Effect of Superficial Thermotherapy Applications in Acute Nonspecific Neck Pain-Randomised Controlled Trial

Acibadem University2 sites in 1 country60 target enrollmentJuly 10, 2024
ConditionsNeck PainCold

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
Acibadem University
Enrollment
60
Locations
2
Primary Endpoint
The Numerical Rating Scale (NPRS-11)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
July 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Nuray Alaca

Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation

Acibadem University

Eligibility Criteria

Inclusion Criteria

  • Being diagnosed with nonspecific neck pain by a doctor,
  • To be between the ages of 18-65,
  • Neck pain lasting for less than 1 month
  • No previous neck or shoulder surgery,
  • No shoulder pain due to any cause,
  • A tumour or inflammatory disease underlying the neck pain not to be found,
  • A clinically underlying stenosis or discogenic problem not to be present.
  • Negative results from the following clinical examination tests;
  • Spurling test, Lhermitte test, Cervical distraction test, Adson test,

Exclusion Criteria

  • Not meeting the inclusion criteria,
  • Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
  • Systemic rheumatological or metabolic diseases or cancer
  • Refusal to participate in the study,
  • Failure to complete treatment,
  • Having any neurological problem
  • Severe psychological illnesses

Outcomes

Primary Outcomes

The Numerical Rating Scale (NPRS-11)

Time Frame: Change from baseline pain score at 3th day

The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

Range of Motion

Time Frame: Change from baseline range of motion at 3th day

CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures

Global Rating of Change scale (Patient Satisfaction)

Time Frame: Change from baseline Global Rating of Change scale at 3th day

Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.

Secondary Outcomes

  • Pressure Pain Threshold(Change from baseline Pressure Pain Threshold at 3th day)
  • Neck disability index(Change from baseline disability scale at 3th day)

Study Sites (2)

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