NCT02983201

Brief Summary

The objective of this trial is to further confirm and assess the efficacy of filiform needle therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack needle therapy could further enhance the clinical efficacy and pain healing effect of the filiform needle therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

October 6, 2016

Last Update Submit

December 1, 2016

Conditions

Pain

Keywords

Orthopedic Pain SyndromesThumbtack Intra-dermal NeedleFiliform needleAcupuncture

Outcome Measures

Primary Outcomes (2)

  • Change of score on Mcgill pain form (SF)

    The change of Score on Mcgill pain form (SF) between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis.

    1 week

  • Change of pain intensity on visual analogue scale (VAS) (1-10)

    The change of pain score on VAS scale between baseline and after the 7th treatment will be measured and compared between groups. Should the patient terminate treatment before the 7th treatment, (due to any reason including cure and drop out), the score of the last treatment will be used for analysis. Follow up phone call will be conducted 3 months after the treatment completed for all patients. The VAS score of the treatment position will be recorded to understand the pain remission pattern between groups

    1 week

Secondary Outcomes (1)

  • The improvement of clinical signs and symptoms

    1 week

Study Arms (2)

filiform needle

ACTIVE COMPARATOR

Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.

Other: filiform needle

thumbtack needle+filiform needle

EXPERIMENTAL

Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.

Other: filiform needleOther: thumbtack needle

Interventions

filiform needleOTHER

Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.

filiform needlethumbtack needle+filiform needle
thumbtack needleOTHER

Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.

thumbtack needle+filiform needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a. Age:\>18 years old
  • b. Gender: male or female
  • c. Duration: not restricted
  • d. Comply with Western medicine diagnostic criteria.
  • e. Signed the Patient/Subject Consent Form for this study.

You may not qualify if:

  • a. The disease is not comply with Western diagnostic criteria.
  • b. The disease is outside the range of this study.
  • c. Acute disease activity phase.
  • d. Skin swelling, skin infection, skin active ulcer disease, or local purpura and scar.
  • e. Patients with skin allergies, bleeding disorders
  • f. Pregnancy, lactating women.
  • g. Application of other therapy, the disease has been or is gradually improving.
  • h. Chronic wasting disease.
  • i. Severe primary diseases of the liver, kidney, hematopoietic system and -endocrine system,
  • j. Mental illness.
  • k. With other severe diseases, it is difficult to exact evaluate the efficacy and safety of acupuncture.
  • l. Not signed the Patient/Subject Consent Form for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong, 852, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lei Li

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li

CONTACT

852-39176424llie@hku.hk

Clara Chan

CONTACT

852-98323934patcla@netvigator.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

December 6, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

CN(1)