Patient Expectations and Dry Needling

NCT04417491 | Completed DMC

• 1 other identifier: URJC5006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.

Conditions

Neck Pain

Keywords

Neck Pain; Needling; Expectance

Outcome Measures

Primary Outcomes (1)

• Changes in Neck Pain Intensity between baseline and follow-up periods

  The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).

  Baseline, immediately after and 1 week after intervention

Secondary Outcomes (2)

• Changes in Pressure pain sensitivity between baseline and follow-up periods

  Baseline, immediately after and 1 week after intervention

• Changes in patients self-perceived improvement between baseline and follow-up periods

  Baseline and 1 week after intervention

Study Arms (2)

Dry Needling

EXPERIMENTAL

The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.

Device: Dry Needling

Sham Needling

SHAM COMPARATOR

The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.

Device: Sham Needling

Interventions

Dry Needling DEVICE

Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited

Dry Needling

Sham Needling DEVICE

Sham dry needling with be conducted with a sham needle device. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient

Sham Needling

Eligibility Criteria

• Age: 18 Months - 65 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Non-specific mechanical neck pain of at least 3 months of duration
• At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms

You may not qualify if:

• whiplash injury;
• previous cervical or thoracic surgery;
• cervical radiculopathy or myelopathy;
• diagnosis of fibromyalgia syndrome;
• having undergone physical therapy in the previous 6 months;
• fear to needles

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

César Fernández-de-las-Peñas

Alcorcón, Rest of the World, 28922, Spain

Location

Related Publications (1)

• Gallego-Sendarrubias GM, Voogt L, Arias-Buria JL, Bialosky J, Fernandez-de-Las-Penas C. Can Patient Expectations Modulate the Short-Term Effects of Dry Needling on Sensitivity Outcomes in Patients with Mechanical Neck Pain? A Randomized Clinical Trial. Pain Med. 2022 May 4;23(5):965-976. doi: 10.1093/pm/pnab134.

  PMID: 33830234 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Proffessor

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 5, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 28, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)