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NCT Number: NCT06507761

Thermotherapy in Acute Nonspecific Neck Pain

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Neck disability index

    Time frame: 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

  2. Pressure Pain Threshold

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nuray ALACA

CONTACT

[email protected]

05324251290

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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