Thermotherapy in Acute Nonspecific Neck Pain

Not Applicable

Recruiting

• Conditions: Neck Pain; Cold
• Interventions: Other: Hot Pack; Other: Sham; Other: Cold Pack

• Registration Number: NCT06507761
• Lead Sponsor: Acibadem University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-10
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-01-10
• Study Completion: 2025-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hot Pack Group	Hot Pack	-
Sham Group	Sham	-
Cold Pack Group	Cold Pack	-

Primary Outcome Measures

Name	Time	Method
The Numerical Rating Scale (NPRS-11)	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	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)	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 Outcome Measures

Name	Time	Method
Pressure Pain Threshold	Change from baseline Pressure Pain Threshold at 3th day	A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Neck disability index	Change from baseline disability scale at 3th day	Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, \> 35 points; complete disability

Trial Locations

Locations (2)

Nuray ALACA; 🇹🇷 Istanbul, Turkey

Acibadem University; 🇹🇷 Istanbul, Turkey