The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.

Detailed Description
-----------------
see above

Official Title
-----------------
Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain

Conditions
-----------------
Neck Pain, Neck Pain Musculoskeletal, Mechanical/Motor Problems With Neck and Trunk

Intervention / Treatment
-----------------
* Procedure: Dry Cupping or fire cupping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 75 permanent neck pain for at least three months in a row a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS) having been in treatment to an orthopaedic or to a neurologist Exclusion Criteria: neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling. invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment. serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment. non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting list control group<br>No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study | |
| Active Comparator: Treatment group<br>Received the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points | Procedure: Dry Cupping or fire cupping<br>* 5 dry cupping treatments, application twice a week, non standardised procedure<br>* Other names: Cupping is: heating glas cups to create a vacuum on the skin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 100mm Visual Analogue Scale | at T2 (Day 25) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain related to movement | 100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001) | at T2 (Day 25) | 
| pain diary | Daily rating of pain intensity (numeric rating scale from 0-10) | from T0 (Day 0) to T2 (Day25) | 
| Neck disability index | NDI measures neck pain complaints (Vernon und Mior 1991) | at T2 (Day 25) | 
| Quality of Life SF-36 | the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998) | at T2 (Day 25) | 
| mechanical detection threshold MDT | by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006) | at T2 (Day 25) | 
| vibration detection threshold VDT | with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006) | at T2 (Day 25) | 
| pressure pain threshold PPT | with a pressure gauge algometer to determine threshold for painful pressure (Rolke, Pain, 2006) on the area of maximal neck pain, the adjacent and hand and foot | at T2 (Day 25) | 
| Side effects | open question on any side effects or other experiences with the treatment | from T1 (Day 7) to T2 (Day 25) | 
| Medication diary | patient report used medication during the study period (amount, dose) | From T0 (Day 0) to T2 (Day 25) |