Thermotherapy in Acute Nonspecific Neck Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain; Cold
• Intervention / Treatment: Other: Sham; Other: Hot Pack; Other: Cold Pack

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuray ALACA; Phone Number: 05324251290; Email: nuray.alaca@acibadem.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey, +90
    • Recruiting
    • Nuray ALACA
    • Contact: Doğa Koçyiğit
  • Istanbul, Turkey, 34752
    • Recruiting
    • Acibadem University
    • Contact: Nuray ALACA; Phone Number: 05324251290; Email: nuray.alaca@acibadem.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Group	Other: Sham; An unrefrigerated room temperature Cold Pack will be wrapped in a towel and applied to the patient's posterior neck and back for 15 minutes while the patient is lying face down.
Active Comparator: Hot Pack Group	Other: Hot Pack; Hot pack (55-60 degrees) application will be wrapped in a towel and applied to the back side neck and back of the patient for 15 minutes while the patient is lying face down.
Active Comparator: Cold Pack Group	Other: Cold Pack; Cold pack application (2-4 degrees) will be wrapped in a towel and applied to the patient's back side neck and back for 15 minutes while the patient is lying prone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Numerical Rating Scale (NPRS-11)	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.	Change from baseline pain score at 3th day
Range of Motion	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	Change from baseline range of motion at 3th day
Global Rating of Change scale (Patient Satisfaction)	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.	Change from baseline Global Rating of Change scale at 3th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck disability index	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	Change from baseline disability scale at 3th day
Pressure Pain Threshold	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).	Change from baseline Pressure Pain Threshold at 3th day

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2024/9/340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No