Thermotherapy in Acute Nonspecific Neck Pain

NCT06507761 | Recruiting

• 1 other identifier: 2024/9/340
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Cold

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Neck disability index

  Change from baseline disability scale at 3th day

• Pressure Pain Threshold

  Change from baseline Pressure Pain Threshold at 3th day

Study Arms (3)

Sham Group

SHAM COMPARATOR

Other: Sham

Hot Pack Group

ACTIVE COMPARATOR

Other: Hot Pack

Cold Pack Group

ACTIVE COMPARATOR

Other: Cold Pack

Interventions

Sham OTHER

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.

Sham Group

Hot Pack OTHER

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.

Hot Pack Group

Cold Pack OTHER

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.

Cold Pack Group

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (2)

Nuray ALACA

Istanbul, +90, Turkey (Türkiye)

RECRUITING

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain; Common Cold

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Nuray ALACA

CONTACT

05324251290; nuray.alaca@acibadem.edu.tr

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

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

TU (2)