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The Covid pandemic has left us with a significant number of people suffering from Long COVID, which is a clinical diagnosis of significant and varying ongoing symptoms at least 12 weeks following COVID-19 infection and characterised frequently by fatigue and breathlessness. Acupuncture has been shown to help breathlessness and fatigue in other conditions including in patients with cancer. Cancer related fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.
We aim to randomise 160 patients, 80 in each arm. Randomisation and recruitment should take 24 months.
Each patient will be offered 6 weeks of weekly acupuncture treatment with a structured questionnaire on wellbeing or no acupuncture with a structure questionnaire on well-being. Both groups of patients will be given continued general advice on management of their symptoms. The next point of involvement will be at 12 weeks which will also be the final visit unless patients in Arm B (Active Control) chose crossover to receive acupuncture. Data at this point will correspond to the end of the participants participation. Over the next 3 months data will be cleaned and analysed.
The primary endpoint is General Fatigue scores, as self-reported by patients using the MFI, at 6 weeks. A 2-unit difference between groups (Acupuncture vs Active Control) in General Fatigue score is considered clinically important.
The secondary endpoints will include differences in scores of various questionnaires and tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Active Comparator |
The acupuncture will be given in 6 sessions at weekly intervals. Delays of up to 2 weeks in delivery of acupuncture are allowed within the protocol. The timing of the study questionnaires at weeks 2, 6 and 12 will remain unchanged. |
|
| Active Control | Active Comparator | Patients randomised to the Active Control will be contacted once per week for 6 weeks for a semi-structured telephone consultation. Delays of up to 2 weeks in delivery of the Active Control session are allowed within the protocol. Patients will be asked during the telephone call to complete the study questionnaires at week 0, 2, 6. Participants will also be asked after the telephone call to rest for 15 minutes if they are able. The patients will also be telephoned on week 12 to complete the study assessments. Patients in Arm B will be required to attend RM in person for the baseline visit and at week 6 to perform the 1 Minute Sit to Stand Test (1-MSTS). The 1-MSTS can be performed virtually rather than in person. Other visits will be telephone calls and completion of questionnaires (paper or via patient portal) Once patients in the Active Control group have completed the 12 week study assessments, they will be offered crossover to receive acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Weekly treatment of 15 minutes for 6 weeks using Seirin 36 g 30 mm needles applied to two upper midline sternal points, thoracic paravertebral points, 5 pairs, 2 bilateral Trapezius trigger points, LI4, TE5, ST36, GB34, SP6, LR3 bilaterally, GV20 & GV24 midline. |
| Measure | Description | Time Frame |
|---|---|---|
| General Fatigue Score | The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory) , at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Acupuncture vs Control
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|
| Active Control | Other | Weekly contact once per week for 6 weeks for a semi-structured telephone consultation. |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |